1832 Pharmacovigilance Jobs - Page 50

Summary Position Summary Title:- Consultant/Sr. Consultant – Life Sciences IT Quality Deloitte’s Life Sciences IT Quality practice is targeted at the life sciences companies combining the competencies of regulatory compliance, technology, operations and automation to help organizations address challenges in an integrated, targeted, and cost-effective manner. Deloitte provides customized solutions with process-driven frameworks backed with automation for clients to achieve their strategic objectives in multiple areas including computerized system validation services (CSV), pharmacovigilance, etc. Work you will do Being part of our team, you are responsible for all the aspects of development, execution, and maintenance pertaining to IT Quality. You will work with clients and engagement teams to help them establish documented evidence that meets regulatory compliance standards by authoring/reviewing deliverables required for regulatory compliance/submission. This is a high visibility role and will drive cross functional collaboration that requires you to provide expertise on Part 11 compliance of ERP systems, regulatory submission systems and other boundary systems/tools, governance, control and execution of people and process, etc. The position provides excellent opportunity to: Identify and manage regulatory risks to support client in regulatory compliance, governance and controls Lead and coordinate cross-functional project teams for new product development and other validation projectsto include reviews, risk analysis and other QA activities in support of systems development and manufacture Assist client in developing strategies for process improvement which caters to the needs of the qualityorganization Author validation strategies and other plans/protocols and summary reports (end-to-end computerized systemvalidation experience is mandatory) Coordinate and interface with R&D, Engineering, Software Development, IT, Manufacturing and QualityAssurance groups to assure successful project execution and end-user training Plan, manage and execute as needed, installation, operational and performance qualifications in accordancewith current Good Manufacturing Practices (cGMPs) Review and approve validation lifecycle documentation Review and identify validation deviations and resolve deviations with appropriate corrective/preventive actions Provide Quality review and assessment of associated change requests related to processes, IT infrastructure,equipments and computer systems?Manage project governance, including providing progress updates of the assigned deliverables, driving timelyclosures of escalations and facilitating strategic decisions with senior management. Initiate trainings and workshops for knowledge transfer and competence building The Team Deloitte's R&OR Life Sciences and Healthcare advisory team combines a broad range of skills providing tailored validation services that addresses regulatory compliance (GxP, Part 11) and, governance and control of process, people and technology. R&OR LSHC practice provides organizations with complete spectrum of services helping them embrace change, grow their business, and emerge resilient following periods of change and disruption. Qualifications And Experience Required : Bachelor’s degree (or equivalent) 2.5 -5 years of experience in pharma or medical device industry with a focus on quality and regulatory compliance Experience in systems validation and quality frameworks Hands on knowledge of software lifecycle approaches (GAMP5, Agile, Waterfall) Hands on project management skills managing medium to large projects with end-to-end validation experience Clear understanding of principles, procedures and governance of validation activities. About Deloitte Deloitte refers to one or more of Deloitte Touche Tohmatsu Limited, a UK private company limited by guarantee (“DTTL”), its network of member firms, and their related entities. DTTL and each of its member firms are legally separate and independent entities. DTTL (also referred to as “Deloitte Global”) does not provide services to clients. In the United States, Deloitte refers to one or more of the US member firms of DTTL, their related entities that operate using the “Deloitte” name in the United States and their respective affiliates. Certain services may not be available to attest clients under the rules and regulations of public accounting. Please see www.deloitte.com/about to learn more about our global network of member firms. Copyright © 2017 Deloitte Development LLC. All rights reserved. Demonstrated analytical and problem solving skills Demonstrated ability to create and direct proposal, and presentation effort Excellent written and oral communication skills. Motivation and skills to work in a team-oriented environment and a desire to work in a company that places high value on cooperation and group achievement Preferred: Master’s Degree In-depth knowledge of pharma and medical device quality systems including design control and manufacturing processes. Understanding of risk management and its application in design and quality systems. #CA-VT Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work. Our purpose Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Professional development From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career. Requisition code: 303484 Show more Show less

Summary Position Summary Title:- Consultant/Sr. Consultant – Life Sciences IT Quality Deloitte’s Life Sciences IT Quality practice is targeted at the life sciences companies combining the competencies of regulatory compliance, technology, operations and automation to help organizations address challenges in an integrated, targeted, and cost-effective manner. Deloitte provides customized solutions with process-driven frameworks backed with automation for clients to achieve their strategic objectives in multiple areas including computerized system validation services (CSV), pharmacovigilance, etc. Work you will do Being part of our team, you are responsible for all the aspects of development, execution, and maintenance pertaining to IT Quality. You will work with clients and engagement teams to help them establish documented evidence that meets regulatory compliance standards by authoring/reviewing deliverables required for regulatory compliance/submission. This is a high visibility role and will drive cross functional collaboration that requires you to provide expertise on Part 11 compliance of ERP systems, regulatory submission systems and other boundary systems/tools, governance, control and execution of people and process, etc. The position provides excellent opportunity to: Identify and manage regulatory risks to support client in regulatory compliance, governance and controls Lead and coordinate cross-functional project teams for new product development and other validation projectsto include reviews, risk analysis and other QA activities in support of systems development and manufacture Assist client in developing strategies for process improvement which caters to the needs of the qualityorganization Author validation strategies and other plans/protocols and summary reports (end-to-end computerized systemvalidation experience is mandatory) Coordinate and interface with R&D, Engineering, Software Development, IT, Manufacturing and QualityAssurance groups to assure successful project execution and end-user training Plan, manage and execute as needed, installation, operational and performance qualifications in accordancewith current Good Manufacturing Practices (cGMPs) Review and approve validation lifecycle documentation Review and identify validation deviations and resolve deviations with appropriate corrective/preventive actions Provide Quality review and assessment of associated change requests related to processes, IT infrastructure,equipments and computer systems?Manage project governance, including providing progress updates of the assigned deliverables, driving timelyclosures of escalations and facilitating strategic decisions with senior management. Initiate trainings and workshops for knowledge transfer and competence building The Team Deloitte's R&OR Life Sciences and Healthcare advisory team combines a broad range of skills providing tailored validation services that addresses regulatory compliance (GxP, Part 11) and, governance and control of process, people and technology. R&OR LSHC practice provides organizations with complete spectrum of services helping them embrace change, grow their business, and emerge resilient following periods of change and disruption. Qualifications And Experience Required : Bachelor’s degree (or equivalent) 2.5 -5 years of experience in pharma or medical device industry with a focus on quality and regulatory compliance Experience in systems validation and quality frameworks Hands on knowledge of software lifecycle approaches (GAMP5, Agile, Waterfall) Hands on project management skills managing medium to large projects with end-to-end validation experience Clear understanding of principles, procedures and governance of validation activities. About Deloitte Deloitte refers to one or more of Deloitte Touche Tohmatsu Limited, a UK private company limited by guarantee (“DTTL”), its network of member firms, and their related entities. DTTL and each of its member firms are legally separate and independent entities. DTTL (also referred to as “Deloitte Global”) does not provide services to clients. In the United States, Deloitte refers to one or more of the US member firms of DTTL, their related entities that operate using the “Deloitte” name in the United States and their respective affiliates. Certain services may not be available to attest clients under the rules and regulations of public accounting. Please see www.deloitte.com/about to learn more about our global network of member firms. Copyright © 2017 Deloitte Development LLC. All rights reserved. Demonstrated analytical and problem solving skills Demonstrated ability to create and direct proposal, and presentation effort Excellent written and oral communication skills. Motivation and skills to work in a team-oriented environment and a desire to work in a company that places high value on cooperation and group achievement Preferred: Master’s Degree In-depth knowledge of pharma and medical device quality systems including design control and manufacturing processes. Understanding of risk management and its application in design and quality systems. #CA-VT Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work. Our purpose Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Professional development From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career. Requisition code: 303484 Show more Show less

Summary Position Summary Title:- Consultant/Sr. Consultant – Life Sciences IT Quality Deloitte’s Life Sciences IT Quality practice is targeted at the life sciences companies combining the competencies of regulatory compliance, technology, operations and automation to help organizations address challenges in an integrated, targeted, and cost-effective manner. Deloitte provides customized solutions with process-driven frameworks backed with automation for clients to achieve their strategic objectives in multiple areas including computerized system validation services (CSV), pharmacovigilance, etc. Work you will do Being part of our team, you are responsible for all the aspects of development, execution, and maintenance pertaining to IT Quality. You will work with clients and engagement teams to help them establish documented evidence that meets regulatory compliance standards by authoring/reviewing deliverables required for regulatory compliance/submission. This is a high visibility role and will drive cross functional collaboration that requires you to provide expertise on Part 11 compliance of ERP systems, regulatory submission systems and other boundary systems/tools, governance, control and execution of people and process, etc. The position provides excellent opportunity to: Identify and manage regulatory risks to support client in regulatory compliance, governance and controls Lead and coordinate cross-functional project teams for new product development and other validation projectsto include reviews, risk analysis and other QA activities in support of systems development and manufacture Assist client in developing strategies for process improvement which caters to the needs of the qualityorganization Author validation strategies and other plans/protocols and summary reports (end-to-end computerized systemvalidation experience is mandatory) Coordinate and interface with R&D, Engineering, Software Development, IT, Manufacturing and QualityAssurance groups to assure successful project execution and end-user training Plan, manage and execute as needed, installation, operational and performance qualifications in accordancewith current Good Manufacturing Practices (cGMPs) Review and approve validation lifecycle documentation Review and identify validation deviations and resolve deviations with appropriate corrective/preventive actions Provide Quality review and assessment of associated change requests related to processes, IT infrastructure,equipments and computer systems?Manage project governance, including providing progress updates of the assigned deliverables, driving timelyclosures of escalations and facilitating strategic decisions with senior management. Initiate trainings and workshops for knowledge transfer and competence building The Team Deloitte's R&OR Life Sciences and Healthcare advisory team combines a broad range of skills providing tailored validation services that addresses regulatory compliance (GxP, Part 11) and, governance and control of process, people and technology. R&OR LSHC practice provides organizations with complete spectrum of services helping them embrace change, grow their business, and emerge resilient following periods of change and disruption. Qualifications And Experience Required : Bachelor’s degree (or equivalent) 2.5 -5 years of experience in pharma or medical device industry with a focus on quality and regulatory compliance Experience in systems validation and quality frameworks Hands on knowledge of software lifecycle approaches (GAMP5, Agile, Waterfall) Hands on project management skills managing medium to large projects with end-to-end validation experience Clear understanding of principles, procedures and governance of validation activities. About Deloitte Deloitte refers to one or more of Deloitte Touche Tohmatsu Limited, a UK private company limited by guarantee (“DTTL”), its network of member firms, and their related entities. DTTL and each of its member firms are legally separate and independent entities. DTTL (also referred to as “Deloitte Global”) does not provide services to clients. In the United States, Deloitte refers to one or more of the US member firms of DTTL, their related entities that operate using the “Deloitte” name in the United States and their respective affiliates. Certain services may not be available to attest clients under the rules and regulations of public accounting. Please see www.deloitte.com/about to learn more about our global network of member firms. Copyright © 2017 Deloitte Development LLC. All rights reserved. Demonstrated analytical and problem solving skills Demonstrated ability to create and direct proposal, and presentation effort Excellent written and oral communication skills. Motivation and skills to work in a team-oriented environment and a desire to work in a company that places high value on cooperation and group achievement Preferred: Master’s Degree In-depth knowledge of pharma and medical device quality systems including design control and manufacturing processes. Understanding of risk management and its application in design and quality systems. #CA-VT Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work. Our purpose Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Professional development From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career. Requisition code: 303484 Show more Show less

Title:- Consultant/Sr. Consultant – Life Sciences IT Quality Deloitte’s Life Sciences IT Quality practice is targeted at the life sciences companies combining the competencies of regulatory compliance, technology, operations and automation to help organizations address challenges in an integrated, targeted, and cost-effective manner. Deloitte provides customized solutions with process-driven frameworks backed with automation for clients to achieve their strategic objectives in multiple areas including computerized system validation services (CSV), pharmacovigilance, etc. Work you will do Being part of our team, you are responsible for all the aspects of development, execution, and maintenance pertaining to IT Quality. You will work with clients and engagement teams to help them establish documented evidence that meets regulatory compliance standards by authoring/reviewing deliverables required for regulatory compliance/submission. This is a high visibility role and will drive cross functional collaboration that requires you to provide expertise on Part 11 compliance of ERP systems, regulatory submission systems and other boundary systems/tools, governance, control and execution of people and process, etc. The position provides excellent opportunity to: Identify and manage regulatory risks to support client in regulatory compliance, governance and controls Lead and coordinate cross-functional project teams for new product development and other validation projectsto include reviews, risk analysis and other QA activities in support of systems development and manufacture Assist client in developing strategies for process improvement which caters to the needs of the qualityorganization Author validation strategies and other plans/protocols and summary reports (end-to-end computerized systemvalidation experience is mandatory) Coordinate and interface with R&D, Engineering, Software Development, IT, Manufacturing and QualityAssurance groups to assure successful project execution and end-user training Plan, manage and execute as needed, installation, operational and performance qualifications in accordancewith current Good Manufacturing Practices (cGMPs) Review and approve validation lifecycle documentation Review and identify validation deviations and resolve deviations with appropriate corrective/preventive actions Provide Quality review and assessment of associated change requests related to processes, IT infrastructure,equipments and computer systems?Manage project governance, including providing progress updates of the assigned deliverables, driving timelyclosures of escalations and facilitating strategic decisions with senior management. Initiate trainings and workshops for knowledge transfer and competence building The Team Deloitte's R&OR Life Sciences and Healthcare advisory team combines a broad range of skills providing tailored validation services that addresses regulatory compliance (GxP, Part 11) and, governance and control of process, people and technology. R&OR LSHC practice provides organizations with complete spectrum of services helping them embrace change, grow their business, and emerge resilient following periods of change and disruption. Qualifications and experience Required : Bachelor’s degree (or equivalent) 2.5 -5 years of experience in pharma or medical device industry with a focus on quality and regulatory compliance Experience in systems validation and quality frameworks Hands on knowledge of software lifecycle approaches (GAMP5, Agile, Waterfall) Hands on project management skills managing medium to large projects with end-to-end validation experience Clear understanding of principles, procedures and governance of validation activities. About Deloitte Deloitte refers to one or more of Deloitte Touche Tohmatsu Limited, a UK private company limited by guarantee (“DTTL”), its network of member firms, and their related entities. DTTL and each of its member firms are legally separate and independent entities. DTTL (also referred to as “Deloitte Global”) does not provide services to clients. In the United States, Deloitte refers to one or more of the US member firms of DTTL, their related entities that operate using the “Deloitte” name in the United States and their respective affiliates. Certain services may not be available to attest clients under the rules and regulations of public accounting. Please see www.deloitte.com/about to learn more about our global network of member firms. Copyright © 2017 Deloitte Development LLC. All rights reserved. Demonstrated analytical and problem solving skills Demonstrated ability to create and direct proposal, and presentation effort Excellent written and oral communication skills. Motivation and skills to work in a team-oriented environment and a desire to work in a company that places high value on cooperation and group achievement Preferred: Master’s Degree In-depth knowledge of pharma and medical device quality systems including design control and manufacturing processes. Understanding of risk management and its application in design and quality systems. #CA-VT Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work. Our purpose Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Professional development From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career. Requisition code: 303484

Summary Position Summary Title:- Consultant/Sr. Consultant – Life Sciences IT Quality Deloitte’s Life Sciences IT Quality practice is targeted at the life sciences companies combining the competencies of regulatory compliance, technology, operations and automation to help organizations address challenges in an integrated, targeted, and cost-effective manner. Deloitte provides customized solutions with process-driven frameworks backed with automation for clients to achieve their strategic objectives in multiple areas including computerized system validation services (CSV), pharmacovigilance, etc. Work you will do Being part of our team, you are responsible for all the aspects of development, execution, and maintenance pertaining to IT Quality. You will work with clients and engagement teams to help them establish documented evidence that meets regulatory compliance standards by authoring/reviewing deliverables required for regulatory compliance/submission. This is a high visibility role and will drive cross functional collaboration that requires you to provide expertise on Part 11 compliance of ERP systems, regulatory submission systems and other boundary systems/tools, governance, control and execution of people and process, etc. The position provides excellent opportunity to: Identify and manage regulatory risks to support client in regulatory compliance, governance and controls Lead and coordinate cross-functional project teams for new product development and other validation projectsto include reviews, risk analysis and other QA activities in support of systems development and manufacture Assist client in developing strategies for process improvement which caters to the needs of the qualityorganization Author validation strategies and other plans/protocols and summary reports (end-to-end computerized systemvalidation experience is mandatory) Coordinate and interface with R&D, Engineering, Software Development, IT, Manufacturing and QualityAssurance groups to assure successful project execution and end-user training Plan, manage and execute as needed, installation, operational and performance qualifications in accordancewith current Good Manufacturing Practices (cGMPs) Review and approve validation lifecycle documentation Review and identify validation deviations and resolve deviations with appropriate corrective/preventive actions Provide Quality review and assessment of associated change requests related to processes, IT infrastructure,equipments and computer systems?Manage project governance, including providing progress updates of the assigned deliverables, driving timelyclosures of escalations and facilitating strategic decisions with senior management. Initiate trainings and workshops for knowledge transfer and competence building The Team Deloitte's R&OR Life Sciences and Healthcare advisory team combines a broad range of skills providing tailored validation services that addresses regulatory compliance (GxP, Part 11) and, governance and control of process, people and technology. R&OR LSHC practice provides organizations with complete spectrum of services helping them embrace change, grow their business, and emerge resilient following periods of change and disruption. Qualifications And Experience Required : Bachelor’s degree (or equivalent) 2.5 -5 years of experience in pharma or medical device industry with a focus on quality and regulatory compliance Experience in systems validation and quality frameworks Hands on knowledge of software lifecycle approaches (GAMP5, Agile, Waterfall) Hands on project management skills managing medium to large projects with end-to-end validation experience Clear understanding of principles, procedures and governance of validation activities. About Deloitte Deloitte refers to one or more of Deloitte Touche Tohmatsu Limited, a UK private company limited by guarantee (“DTTL”), its network of member firms, and their related entities. DTTL and each of its member firms are legally separate and independent entities. DTTL (also referred to as “Deloitte Global”) does not provide services to clients. In the United States, Deloitte refers to one or more of the US member firms of DTTL, their related entities that operate using the “Deloitte” name in the United States and their respective affiliates. Certain services may not be available to attest clients under the rules and regulations of public accounting. Please see www.deloitte.com/about to learn more about our global network of member firms. Copyright © 2017 Deloitte Development LLC. All rights reserved. Demonstrated analytical and problem solving skills Demonstrated ability to create and direct proposal, and presentation effort Excellent written and oral communication skills. Motivation and skills to work in a team-oriented environment and a desire to work in a company that places high value on cooperation and group achievement Preferred: Master’s Degree In-depth knowledge of pharma and medical device quality systems including design control and manufacturing processes. Understanding of risk management and its application in design and quality systems. #CA-VT Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work. Our purpose Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Professional development From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career. Requisition code: 303484 Show more Show less

Summary Position Summary Title:- Consultant/Sr. Consultant – Life Sciences IT Quality Deloitte’s Life Sciences IT Quality practice is targeted at the life sciences companies combining the competencies of regulatory compliance, technology, operations and automation to help organizations address challenges in an integrated, targeted, and cost-effective manner. Deloitte provides customized solutions with process-driven frameworks backed with automation for clients to achieve their strategic objectives in multiple areas including computerized system validation services (CSV), pharmacovigilance, etc. Work you will do Being part of our team, you are responsible for all the aspects of development, execution, and maintenance pertaining to IT Quality. You will work with clients and engagement teams to help them establish documented evidence that meets regulatory compliance standards by authoring/reviewing deliverables required for regulatory compliance/submission. This is a high visibility role and will drive cross functional collaboration that requires you to provide expertise on Part 11 compliance of ERP systems, regulatory submission systems and other boundary systems/tools, governance, control and execution of people and process, etc. The position provides excellent opportunity to: Identify and manage regulatory risks to support client in regulatory compliance, governance and controls Lead and coordinate cross-functional project teams for new product development and other validation projectsto include reviews, risk analysis and other QA activities in support of systems development and manufacture Assist client in developing strategies for process improvement which caters to the needs of the qualityorganization Author validation strategies and other plans/protocols and summary reports (end-to-end computerized systemvalidation experience is mandatory) Coordinate and interface with R&D, Engineering, Software Development, IT, Manufacturing and QualityAssurance groups to assure successful project execution and end-user training Plan, manage and execute as needed, installation, operational and performance qualifications in accordancewith current Good Manufacturing Practices (cGMPs) Review and approve validation lifecycle documentation Review and identify validation deviations and resolve deviations with appropriate corrective/preventive actions Provide Quality review and assessment of associated change requests related to processes, IT infrastructure,equipments and computer systems?Manage project governance, including providing progress updates of the assigned deliverables, driving timelyclosures of escalations and facilitating strategic decisions with senior management. Initiate trainings and workshops for knowledge transfer and competence building The Team Deloitte's R&OR Life Sciences and Healthcare advisory team combines a broad range of skills providing tailored validation services that addresses regulatory compliance (GxP, Part 11) and, governance and control of process, people and technology. R&OR LSHC practice provides organizations with complete spectrum of services helping them embrace change, grow their business, and emerge resilient following periods of change and disruption. Qualifications And Experience Required : Bachelor’s degree (or equivalent) 2.5 -5 years of experience in pharma or medical device industry with a focus on quality and regulatory compliance Experience in systems validation and quality frameworks Hands on knowledge of software lifecycle approaches (GAMP5, Agile, Waterfall) Hands on project management skills managing medium to large projects with end-to-end validation experience Clear understanding of principles, procedures and governance of validation activities. About Deloitte Deloitte refers to one or more of Deloitte Touche Tohmatsu Limited, a UK private company limited by guarantee (“DTTL”), its network of member firms, and their related entities. DTTL and each of its member firms are legally separate and independent entities. DTTL (also referred to as “Deloitte Global”) does not provide services to clients. In the United States, Deloitte refers to one or more of the US member firms of DTTL, their related entities that operate using the “Deloitte” name in the United States and their respective affiliates. Certain services may not be available to attest clients under the rules and regulations of public accounting. Please see www.deloitte.com/about to learn more about our global network of member firms. Copyright © 2017 Deloitte Development LLC. All rights reserved. Demonstrated analytical and problem solving skills Demonstrated ability to create and direct proposal, and presentation effort Excellent written and oral communication skills. Motivation and skills to work in a team-oriented environment and a desire to work in a company that places high value on cooperation and group achievement Preferred: Master’s Degree In-depth knowledge of pharma and medical device quality systems including design control and manufacturing processes. Understanding of risk management and its application in design and quality systems. #CA-VT Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work. Our purpose Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Professional development From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career. Requisition code: 303484 Show more Show less

Medical Coding is the process of converting Verbal Descriptions into numeric or alpha numeric by using ICD 10-CM, CPT && HCPCS. As per HIPAA rules healthcare providers need efficient Medical Coders. Qualification & Specifications : MBBS,BDS,BHMS,BAMS,BSMS,PHARMACYB.Sc/M.Sc (Life Sciences / Biology / Bio Chemistry / Micro Biology / Nursing / Bio Technology), B.P.T, B.E BIOMEDIAL, B.Tech (Biotechnology/Bio Chemistry). 2018 -2024 passed out Skills Required: * Candidates should have Good Communication & Analytical Skills and should be Good at Medical Terminology (Physiology & Anatomy). Role: To review US medical records Initial file review for identifying merits Subjective review and analysis to identify instances of negligence, factors contributing to it To review surgical procedures, pre and post-surgical care, nursing home negligence To prepare medical submissions To prepare the medical malpractice case Regards Pujitha +917200052460

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe. Job Overview Lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports. Demonstrate the ability to independently manage the production of safety deliverables, including those involving complex data analyses or important safety issues. Act as a technical lead of the medical writing teams across projects and provide guidance and expertise for developing high-quality scientific content as required for various safety deliverables. Establish good client communication and coordination within writing teams to manage stakeholder expectations and resolve any issues surrounding project/report deliverables. Contribute to scientific publications and represent the company at scientific meetings and conferences. Work with the project management team to implement quality and process improvement initiatives. Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time. Summary Of Responsibilities Write and review various safety reports for global regulatory submissions for clients, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Development Safety Update Report, Clinical Overviews, Medical Device reports, and other documents as assigned. Lead the end-to-end process of report production and ensure the required quality standards and key timelines are met. Provide oversight to co-authors or team of writers as applicable and be accountable for the quality of their work/contributions. Act as the primary point of contact for the client for all report management activities. Engage in client communication to manage stakeholder expectations, present anticipated challenges, propose remediation, and escalate unresolved issues impacting deliverables at an individual report or project level. Author/review RMPs, ad hoc reports, Benefit-Risk Evaluation reports, supporting documents for label updates, reports of effectiveness of risk minimization measures or enhanced pharmacovigilance activities. Lead/participate in various steps of the signal management process. Provide inputs for developing signal strategies and retrieval of data from safety databases, scientific literature, and other sources, as required. Author/review signal evaluation/management reports (ad hoc and periodic) and safety issue analysis reports. Participate in safety/benefit-risk review meetings with clients, discuss results and conclusions from signal/safety analysis, and in collaboration with the safety physician, propose label updates and other risk mitigation measures, as needed. Draft responses (or parts thereof) to health authority questions or feedback and collaborate with cross functional stakeholders in the management and tracking of such feedback. Develop abstracts, posters, manuscripts, and other documents for scientific publication or presentation at conferences or pharmacovigilance forums. Prepare medical information responses for HCPs. Act as a writing coach, provide regular quality feedback, conduct training, and share best practices with associates for promoting the use of clear and concise writing and adherence to style guides, as applicable. Support project management activities such as maintenance of project schedules and tracking of metrics and compliance. Contribute to business development activities, including estimation of resource requirement and responding to RFPs. Create and update labels, e.g. Core Data Sheets, USPI, centralized SPC’s, Med Guides. Conduct literature reviews, formulate and execute search strategies, including those for complex topics or research questions. Implement and promote use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures and assume accountability for the deliverables. Ensure compliance of operations with governing regulatory requirements. Create, maintain, and assume accountability for a culture of high customer service. Perform any additional activities per project requirement or at the manager’s discretion upon completion of relevant training. And all other duties as needed or assigned. Qualifications (Minimum Required) Minimum of first degree in life sciences (or equivalent). Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required) At least 5-7 years of experience in the pharmaceutical industry, with at least 4 years of it in medical writing. Excellent command of written and spoken English. Good written and verbal communication skills. Knowledge of MS Office. Good organizational and time management ability. Excellent interpersonal and leadership skills. Scientific or clinical research or medical writing experience desirable. Good understanding of regulatory requirements, good Pharmacovigilance practices and ICH GCP guidelines. Excellent understanding of pharmaceutical product development cycle. Extensive knowledge of guidelines and regulations pertaining to regulatory submissions for US, EU and emerging markets. Ability to work independently, train and impart knowledge, coach, and mentor team members. Overall understanding of requirements for all types of regulatory documents. Help project managers/deliver managers in managing operations, performance, etc. Preferred Qualifications Include Advanced degree (e.g., PhD or Masters). Experience in drug discovery and pharmacovigilance is desirable. Physical Demands/Work Environment Office environment or remote. Available for travel 15% of the time including overnight stays as necessary consistent with project needs and office location. Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com. Fortrea Is Proud To Be An Equal Opportunity Employer As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply. For more information about how we collect and store your personal data, please see our Privacy Statement. If you require a reasonable accommodation to complete your job application, pre-employment testing, job interview or to otherwise participate in the hiring process, please contact: taaccommodationsrequest@fortrea.com. Please note that this e-mail address is only for job seekers requesting an accommodation. Please do not use this e-mail to check the status of your application. Show more Show less

Position Title: Chief Exports Officer (International Business) Job Description: Chief Exports Officer Location: Chandigarh/Panchkula | India Reports To: International Business Leadership Team Leadership: All International Business teams Our Company: We are a distinguished, mid-sized Indian pharmaceutical leader, financially robust with revenues of approximately 700 crores and a dedicated team of 1400+ professionals. Our products reach over 90 countries, supported by two European subsidiaries. We are currently undertaking significant capital-intensive projects, all while adhering to an unwavering, highly conservative financial strategy: zero external funding (debt, equity, or hybrid instruments) and absolute compliance with all applicable laws. Our growth is exclusively driven by internal accruals, underpinned by financial prudence and uncompromising integrity in financial reporting and management. The Opportunity : Architect of Global Pharmaceutical Sales & Market Dominance The Chief Exports Officer (CXO) will be entrusted with the strategic and operational command of Venus's international commercial business, with a primary focus on driving tangible sales and P&L ownership. This pivotal role is central to achieving our ambitious global growth targets by not just identifying opportunities but by masterfully navigating the complex regulatory, procurement, and logistical landscapes inherent in the international pharmaceutical sector, especially for sterile injectables. The CXO will lead a high-performing global sales organization, ensuring that business development efforts translate into active, revenue-generating markets. You will harmonize cross-functional partnerships and elevate Venus's international business to new frontiers of scale, sophistication, and sustainable profitability by ensuring Marketing Authorizations (MAs) are actively commercialized and sales targets are met. Key Responsibilities : Driving Global Pharmaceutical Sales & Operational Excellence Global Sales Execution & Commercial Strategy (Primary Focus): Own full P&L accountability and drive sales revenue across all international markets (developed, semi-regulated, emerging), with a specific focus on maximizing returns from existing and new MAs. Define, cascade, and rigorously monitor quarterly and annual sales targets and market share objectives, ensuring direct alignment with corporate goals. Architect and execute continent-wise commercial strategies that address pharmaceutical-specific market access challenges (including local presence requirements, import/export controls, batch clearance/testing protocols), portfolio optimization (especially for sterile injectables), pricing dynamics, and diverse regulatory timelines. Leverage deep market intelligence (IMS, tender databases, competitive benchmarking) to guide proactive sales execution, not just opportunity identification. Deliver consistent growth through a mix of organic sales from existing MAs, strategic launches of new products, and effective lifecycle management of registered products to prevent dormant MAs. Strategic Business Development & Sustainable Market Entry: Lead international customer acquisition efforts, identifying and securing business with institutional buyers, distributors, hospital groups, and public procurement agencies, ensuring a clear path to sales post-agreement. Formulate market entry strategies for untapped geographies, incorporating rigorous due diligence on local pharmaceutical regulatory feasibility, procurement procedures, shipping logistics, and profitability analysis before committing resources. Build Venus's positioning in global tenders and institutional platforms, focusing on optimized bid economics and successful conversion into sales contracts. Ensure long-term value creation by establishing robust in-market sales processes, regulatory support, and after-sales systems. Mergers, Acquisitions & Strategic Collaborations (Supporting Sales Growth): Identify, evaluate, and pursue M&A, in-licensing, and commercial alliances that offer clear pathways to accelerated sales growth and market penetration. Lead commercial due diligence with a strong emphasis on assessing the sales potential and integration complexities within target markets. Oversee integration strategies post-acquisition/alliance, ensuring rapid activation of sales channels and operational alignment. Organizational Leadership & Pharma-Specific Market Intelligence: Lead and develop a continent-wise regional sales structure, empowering teams with autonomy, accountability, and deep knowledge of local pharmaceutical regulations, procurement cycles, and sales execution tactics. Promote a culture of sales ownership, discipline, agility, and accountability, with a strong performance management framework tied to sales outcomes. Ensure teams are tuned into real-time market dynamics and regulatory shifts, responding with speed and precision to secure and grow sales. Cross-Functional Alignment for Sales Enablement Drive seamless execution through structured coordination between regional sales leads and core support functions critically Regulatory Affairs (for MA approvals, variations, and compliance), Quality, Supply Chain (for uninterrupted product flow), Finance, Artwork, and Logistics via the International Business Support Department. Institutionalize SOPs that prioritize efficient MA processing, rapid response to regulatory queries, and streamlined order-to-cash cycles. Digital Enablement & Sales Performance Intelligence: Champion the deployment of CRM systems, BI dashboards, tender intelligence tools, and digital sales trackers to monitor, drive, and optimize sales performance across all markets. Integrate predictive analytics and real-time reporting into sales forecasting, customer targeting, competitive positioning, and proactive MA lifecycle management. Ideal Candidate Profile: Essential Qualifications: Master of Business Administration (MBA) or equivalent postgraduate management degree is mandatory. A foundational Bachelors degree in Pharmacy, Life Sciences, Business, or a related field is required. Certifications in international trade, pharmaceutical marketing, or regulatory affairs would be an advantage. Depth of Experience: . Indispensable, hands-on experience managing the export and sales of pharmaceutical products, particularly sterile injectables, across a significant global footprint (ideally covering diverse regulatory environments across multiple continents, akin to operations in nearly 100 countries). Proven P&L ownership and direct accountability for achieving substantial sales revenue targets in international markets, demonstrating a track record of turning Marketing Authorizations into consistent, profitable revenue streams and effectively managing the lifecycle of registered products to maximize commercial returns. Crucial experience in successfully navigating the complex, country-specific regulatory approval processes, procurement systems (government, institutional, private), import/export controls, customs clearance, batch testing/release protocols, and local presence requirements inherent to the pharmaceutical industry in developed, semi-regulated, and emerging markets. Demonstrable success in building and leading high-performing, continent-wise or global sales teams, including establishing effective distributor networks, winning large-scale international tenders, and managing direct sales forces. Experience in identifying, evaluating, and integrating international M&A, strategic alliances, or in-licensing deals with a clear focus on post-transaction sales acceleration and market share growth. Critical Skills & Knowledge: Mastery of global pharmaceutical sales strategies, commercial execution tactics, and international business development, with a strong emphasis on market penetration and sales realization. Expert-level understanding of the international pharmaceutical regulatory landscape, including GMP, MAA processes (e.g., country-specific, regional like EMA), variations, pharmacovigilance, and compliance requirements across diverse geographies. In-depth knowledge of international trade finance, logistics, supply chain complexities for temperature-sensitive products (like sterile injectables), and Incoterms. Proficiency in leveraging market intelligence (e.g., IMS data, tender portals), CRM systems, and BI tools to drive sales forecasting, performance management, and strategic decision-making. Exceptional negotiation, influencing, and communication skills, with proven ability to build robust relationships with key opinion leaders, regulatory authorities, major distributors, and institutional buyers globally. Strong financial acumen, with the ability to manage budgets, develop pricing strategies, analyze profitability, and optimize bid economics for international tenders. Personal Attributes & Mindset: Unwavering sales-driven orientation with a relentless focus on achieving and exceeding targets; high degree of commercial hunger and P&L accountability. Highly resilient, adaptable, and resourceful, with the ability to thrive under pressure and navigate complex, multicultural business environments. Exceptional leadership qualities: inspirational, decisive, and able to motivate and develop globally dispersed teams. Impeccable ethical standards and integrity; a commitment to compliant and responsible business practices. Culturally astute with high emotional intelligence, fostering collaborative relationships across diverse internal and external stakeholder groups. Preferred Additional Experience: Direct experience in establishing new market operations, joint ventures, or local manufacturing/packaging partnerships in key international territories. Specific therapeutic area expertise relevant to the company's portfolio beyond sterile injectables. Show more Show less

Looks Studio is looking for Doctor to join our dynamic team and embark on a rewarding career journey Patient Consultations: Conduct thorough consultations with patients to understand their goals, concerns, and medical histories, and provide expert recommendations for appropriate surgical or non-surgical interventions. Surgical Procedures: Perform a variety of plastic and cosmetic surgical procedures, such as breast augmentation, liposuction, rhinoplasty, facelifts, tummy tucks, and reconstructive surgeries. Preoperative Assessments: Evaluate patients' physical and mental suitability for surgery, order necessary preoperative tests, and educate patients on preoperative and postoperative care. Treatment Plans: Develop individualized treatment plans tailored to each patient's unique needs and desired outcomes, explaining risks, benefits, and potential outcomes. Surgical Techniques: Utilize advanced surgical techniques, technology, and tools to achieve optimal results while ensuring patient safety and minimizing risks. Non-Surgical Procedures: Offer and perform non-surgical cosmetic procedures such as Botox injections, dermal fillers, laser treatments, and chemical peels. Postoperative Care: Provide postoperative care, follow-up appointments, and ongoing support to ensure patients' smooth recovery and satisfactory results. Qualification: MDS-OMFS Experience: Well experienced in the field of cosmetic surgery and hair transplant. Freshers who are hard working, dedicated an

Shenoy Hospital is looking for Sr.Pharmacist / Incharge to join our dynamic team and embark on a rewarding career journey Dispense medications and provide pharmaceutical care to patients. Advise patients and healthcare providers on the proper use of medications. Manage pharmacy inventory and ensure the availability of essential drugs. Ensure compliance with pharmaceutical regulations and standards. Maintain accurate patient records and medication histories. Provide training and support to pharmacy staff. Good communication skills Atleast 2 to 3 years of experience as Pharmacist Must be Qualified B.Pharmacy/D.Pharmacy with Certified P

Preparing interview questions, communicating and interacting with patients,and summarizing results. Liaising with laboratories regarding research findings. Monitoring the study to ensure that it complies with protocols. Directing the collection, labelling, storage, and transport of all specimen. Noting the clinical data from records, recording dietary intake patterns, physical activity, sample separation, and patient follow-up. Analyze data using various statistical methods and maintain accurate and complete records. Co-ordinate with Bioinformaticians, Genetic Counselors, Clinicians, and clinical geneticists for data analysis. Reviews and processes orders for laboratory procedures for patient samples. Demonstrate strong scientific and communication skills. Maintain precise and up-to-date documentation of the ethics, biosafety committee, and DSIR. Overseeing the trouble-free running of patient's enrolment for research studies. M.Sc./B.Sc. in life science (Biotechnology/Medical Microbiology / Microbiology / Medical Biochemistry) Minimum of 1 year work experience for M.Sc./B.Sc., and expertise in counseling patients and dry lab techniques.

TCS is hiring for Medical Reviewer!!! Job Location Mumbai/Pune/Bangalore Experience Range – 1 to 6 Years Educational Qualification(s) Required – MBBS/MD Interested can share their CV on babeeta.shahi@tcs.com Accountable for the medical review of relevant clinical, other solicited and spontaneous cases (including literature articles), medical assessment (including labeling and causality along with the company causality statement) Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history Developing and maintaining thorough knowledge of the appropriate disease biology areas & important safety concerns for marketed drugs and drugs in development Assuring and maintaining compliance with regulatory and local/global SOP timelines. Supporting the Drug Safety teams with medical concepts and awareness of product related topics to ensure quality of adverse event data processing Representing safety physician team in internal and client safety forums and audits Review and respond to any queries/comments for an individual case safety report in the Patient Safety database.

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description: Objective / Purpose : This is a key position in GI2 TAU clinical science to accelerate the drug development in India, and belongs to organization of RnD China & APAC. This role is the local clinical lead to drive the drug development from clinical development strategy establishment to local registration in India as member of China Asia Development Team, with close collaboration with cross function team members of CADT, India Development Lead, India business operation and other relevant global and local stakeholders. In some cases, the scope may be extended to other Asia countries/regions besides India based on the business needs. Leads and drives local strategy and clinical development plan taking into consideration the medical, scientific, regulatory and commercial issues for the assigned Takeda pipeline compound(s) in GI2. Interacts with and influences Takeda’s senior leadership decision-making by setting strategic direction locally. Cultivates and manage relationships with local KOLs and investigators. Play a crucial role as the local clinical lead for the assigned studies, including the development of study concept, synopsis, protocol, booster enrollment engagement activities, study conduction, databased lock, data interpretation, and etc. Applies clinical expertise as the local clinical lead for the CTA, NDA, and the interaction with local Health Authorities. Accountabilities : Clinical Development team participation and leadership: Leads and drives local clinical development strategy and deliverables for GI2 pipeline assets, including the Development Strategy, Clinical Development Plan and Clinical Protocols. Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet regulatory submission and approval goals locally. Leads or supports high impact decisions based on strong clinical/scientific expertise as well as leadership monitors and interprets data from ongoing internal and external studies, assessing the medical and scientific implications, and making recommendations that impact local and global development such as “go/no go” decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling. Synopsis / Protocol Development, Study Execution & Study Interpretation: Drives clinical science activities relating to the preparation / approval of synopsis, protocols and the conduct of clinical studies. Accountable for the successful design and interpretation of clinical studies. Presents study conclusions to Management and determine how individual study results impact the overall compound strategy. Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients. Booster enrollment activities and: Trial Medical Monitoring: Provides strong supports to the local booster enrollment activities from clinical perspective Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses safety information for studies and compound in conjunction with Pharmacovigilance. External Interactions: Directs activities involved in interactions with local regulatory authorities / agencies and clinical development activities undertaken to establish and maintain strong relationships with local key opinion leaders. Leads collaboration with academia, local development network to advance drug development in India. Lead roles will also be taken on the incorporation of advice / recommendations received into the design of clinical studies/programs as appropriate, and ensuring these activities are aligned with the RnD China&APAC region and global strategy .: : Due Diligence, Business Development and Alliance Projects: May participate in due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities. Assesses scientific, medical, and development feasibility, evaluating complete or ongoing clinical trials, assessing local regulatory interactions and future development plans, and representing clinical science on internal assessment teams in conjunction with other parts of the organization. Leadership, Influence, Leading Capability Development: , Communication and Collaboration Capability Development,: and M: ultidisciplinary Task Force: Demonstrates strong leadership and clinical/scientific expertise to influent key internal stakeholders from RnD China & APAC and global about pipeline/compound strategy and decision making. Proactively leads TA capability development by coaching and mentoring to local team members; advocates and creates share-learning and growth supportive environment. Proactively leads and contributes in multidisciplinary task forces on across divisions representing clinical science to increase local team/organization capability and efficiency. Embraces innovation, diversity and inclusive culture in teams/organization and leading as a local role model, brandings RnD China&APAC on behalf of GI2 Clinical Science team. Keep strong communication and collaboration capability with the team members to ensure high quality and timely deliverables. Education & Competencies : MD or internationally recognized equivalent plus minimum 15 years of clinical practice and/or research experience. Direct experience in GI2 therapy pharmaceutical development, or related field required Previous experience of influencing senior-level management and key stakeholders is a plus Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in India. The experience in other Asia countries/regions is a plus. Fluent in English and Indian. NDA/MAA/Submission experience preferred Management experience Excellent communication and collaboration skills Models the Takeda Leadership Behaviors Locations: IND - Bengaluru Worker Type: Employee Worker Sub-Type: Regular Time Type: Full time Show more Show less

About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. Job Description / Capsule Field based scientific experts in assigned therapeutic area that is responsible in the execution of the Medical Affairs Plan(s) for pre-launch and/or newly launched products/indications. Shapes clinical practice through scientific engagements, partnerships and collaborations with traditional (e.g Specialist KEEs for MSLs & Primary Care Physicians for CSLs), and where appropriate non-traditional (e.g. policy and decision makers, PAGs, government, innovative solution providers) experts, as well as, with internal stakeholders to drive enhanced patient outcomes and the safe and effective use of AstraZeneca medicines. Developing and enhancing professional relationships and partnerships with healthcare professionals and other healthcare ecosystem stakeholders according to the Integrated Engagement Plan. Provides scientific, technical, and pharmaco- economic information to HCPs and key stakeholders through one-on-one discussions and medically lead meetings as experts and confidence generation activities. Can be involved and may lead evidence generation activities as part of the implementation of the medical strategy. Acts as catalysts, with a deep understanding of the health system (environment, priorities, clinical pathways, patient journeys) and its challenges, to gather insights and execute according to the medical strategic plans to deliver strategic, scalable & sustainable clinical practice transformations, enhancing access to equitable quality care for patients and enabling the adoption of our innovative medicines. Scientific Expertise: Maintain clinical/scientific expertise in disease state management, AstraZeneca products, emerging therapies, and the competitive landscape. Contribute to the development and provide project leadership/ management of the therapeutic area Field Medical Strategic Plan (FMSP). Act as a subject matter expert/resource for internal and external stakeholders. Work with internal stakeholders in the development and delivery of appropriate training and mentoring needs within therapeutic area. Scientific Exchange: Engage in peer-to-peer level dialogue with key customers and deliver appropriate clinical/scientific content through utilising the correct channel mix, which will differentiate AstraZeneca products from those of other companies. Respond to unsolicited customer inquiries and provide focused and balanced clinical / scientific information that supports the safe and appropriate use of AstraZeneca’s products and services. Provide scientific/clinical support and deliver presentations to internal and external stakeholders. Identify and establish relationships with key customers and other scientific thought leaders for engaging them in ongoing scientific dialogue on AstraZeneca products and unsolicited discussions about compounds in development. Organize and facilitate scientific events such as MSL events, Symposiums, Scientific Exchanges, Advisory Boards/Expert Panels, non-promotional standalone events, Meet the Professor sessions, etc., with KEEs and HCPs. Prioritize these events based on their relevance in the patient journey for the related disease. Deliver informative lectures at scientific events tailored to healthcare professionals, aligning with the field medical. Customer Insight: Effectively identify, gather, analyse, synthesise, report and forward relevant new knowledge about the external scientific/medical environments to internal stakeholders Provide internal stakeholders with actionable items related to medical / product strategy or clinical development based on customer perspectives. Partner with traditional and non-traditional stakeholders to identify gaps in the patient experience journey as insights to be included in the medical / product strategies. Strategic Relationship: Develop peer-level relationships with medical and scientific experts, including Healthcare Professionals and collaborate with other internal teams for other key external stakeholders (e.g. policy and decision makers, PAGs, government, innovative solution providers) consistent with Medical objectives. Identify pre-clinical, clinical, and post-marketing study investigators in alignment with Medical Plans. Support data generation activities including participating in reviews of Investigator sponsored studies. Looks to broaden the My MA contact list where appropriate to include non-traditional KEEs from government, payer groups, researchers and clinical advisors who may support practice change initiatives. Establish win-win partnerships with traditional and non-traditional stakeholders to deliver on strategic, scalable and sustainable solutions addressing patient healthcare access gaps within the ecosystem. Other: Responsible for leveraging digital and innovation / technology as enablers for scientific exchange and creating patient centric solutions. Possesses a solid grasp of pharmacovigilance and GxP principles, showcasing a clear understanding of their significance. This includes practical knowledge of Good Clinical Practice (GCP), various types of clinical studies, and requirements for reporting adverse events (AEs). Possesses a solid grasp of pharmacovigilance and GxP principles, showcasing a clear understanding of their significance. This includes practical knowledge of Good Clinical Practice (GCP), various types of clinical studies, and requirements for reporting adverse events (AEs). Exhibits a robust understanding of the Ethical Interactions Policy, along with relevant standards, local laws, and regulations. Moreover, possesses the ability to provide training to others in this domain. Adherence to internal processes and AstraZeneca Global Field Medical Standards and the external regulations including but not limited to clinical trials, promotional activity (e.g. Local Code of Conduct) and pharmacovigilance activities to meet internal SOP and local regulations. Essential Education, Qualifications, Skills and Experience Scientific and or a master’s degree in a scientific discipline Excellent oral and written communication and interpersonal skills Ability to communicate internally and externally using the different channel mix. Excellent project management skills Excellent presentation skills High level analytical and conceptual thinking Desirable Doctoral degree in a scientific discipline (e.g. M.D., Ph.D., Pharm.D.) Experience in pharmaceutical industry, regulatory environment, clinical or preclinical research, and knowledge of a therapeutic area disease state and treatment. Experience with basic research, drug discovery, drug development and KEE interactions. Why AstraZeneca? At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare. Show more Show less

Job title: Sr. Specialist Quality Services (Product Complaints) Location: Hyderabad About The Job Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines. Main Responsibilities Handle Product Technical Complaints (PTC) for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards. Collaborate with internal/external stakeholders viz Cross functional teams, Manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management departments for complaint management, Contract manufacturing organization. Enter complaints into the global database and evaluate complaints for severity and risk, ensure timely processing and closure of the complaints. Manages and ensures the compliance of all Quality processes and documentation with applicable regulations/ Sanofi standards. Handle QMS records & any discrepancies and ensure completion within defined timelines. Ensure investigation management and coordination with internal and external partners (including tracking and monitoring of investigations). Review & closure of investigation reports to ensure correctness, completeness, and adherence to standards including root cause analysis, CAPA, assessment and prioritization. Collection, visualization & analysis of complaint data. Preparation of trend reports of complaints related to products, sites, EMS & Countries defined as per procedure. About You Experience: 3 - 7 Years Experience. Education: Graduate in Pharmacy or life sciences or Engineering or Biotechnology. Languages: English, Hindi is preferred Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks’ gender-neutral parental leave. Opportunity to work in an international environment, collaborating with diverse business teams and vendors, working in a dynamic team, and fully empowered to propose and implement innovative ideas. null Show more Show less

Job Overview Provide medical expertise on pharmacovigilance services to divisions as requested. The Associate Medical Safety Director participates in all aspects of Medical Safety’s involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors. Essential Functions Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data Represent safety and clinical data review findings during client meetings Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies Provide medical oversight for label development, review and change Provide medical support and attendance at Data Safety Monitoring Board Meetings Attends and contributes medical safety evaluation on Safety Monitoring Committees Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture. Act as Global Safety Physician or Assistant or Back-up on projects as assigned Attend project meetings, medical safety team meetings, and client meetings as requested Ensure coverage for all medical safety deliverables within regulatory or contracted timelines Provide medical escalation support for medical information projects Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects 24 hour medical support as required on assigned projects Maintain awareness of medical-safety-regulatory industry developments Line manage a team of regionally based physicians performing the tasks of a global medical safety physician ensuring operational delivery of assigned projects and professional development of direct reports Participate in the Global Medical Safety Management Team to drive service line growth, differentiation, and strategy Represent global medical safety service line to regional stakeholders, internal and external Hold at least bi-monthly meetings with direct reports to discuss, at a minimum: project status, including timelines, delivery updates, financial aspects of the group or project, and potential risks, associated mitigation and support required; status of any initiatives that they may be involved in; the team's utilization rates; the direct report's training and other administrative obligations, such as Standard Operating Procedures (SOPs) and corporate training mandates; personnel issues; and career or training objectives. Create and implement plans for measuring and improving employee engagement ensuring global consistency. Maintain open and regular communication with direct reports to ensure a supportive working environment. Efficiently conveying messages from leadership to direct reports and teams, as well as effectively communicating issues and opportunities up to leadership. Might be needed to serve as the designated substitute or alternatively ensure coverage is in place for direct reports during their absence or in case of turnover. Prepare, present and respond in bid defense meetings and discussions. May input into more complex requests for information (RFIs) or requests for proposal (RFPs). Liaise with Business Development to give timely inputs regarding the feasibility of all new proposals going out to clients. Contribute at IQVIA internal cross-functional project team meetings interfacing with other functional leads customer project status meetings and oversight group meetings. Subject Matter Expert (SME) Meetings, as appropriate. Qualifications Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education Req Three (3) years of clinical practice experience (e.g graduate medical training) with two (2) additional years in the pharmaceutical or associated industry in any role. Or equivalent combination of education, training and experience Req Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice Knowledge of clinical trials and pharmaceutical research process Strong business acumen; financial management and budgeting skills. Proven Staff management skills, strong leadership, motivational and influencing skills. Strong project management; strategic planning; delegation and organisational skills. Proven ability to work on multiple projects and manage competing priorities. Confident in raising and discussing sensitive topics without management intervention and in communicating effectively with senior levels of management in both IQVIA and customer organizations. Demonstrated ability to remain calm and assertive yet diplomatic in more challenging interactions with customers and colleagues. Excellent communication (both verbal and written), presentation and negotiation skills. Ability to establish and maintain effective working relationships with coworkers, direct reports, managers, and customers at a senior level. Autonomous independent decision-making; problem solving and judgment skills. Strong customer focus; account and alliance management and experience in customer contracting models. Proven ability to professionally network; present and lead at meetings/ teleconferences. Ability to achieve results through communication, facilitation, negotiations in a matrix service delivery environment with shared responsibilities. Demonstrate excellent flexibility; self-motivation; creativity; innovation and solutions driven approach. Demonstrates financial awareness. Promotes good practices to manage financial performance Strong ownership skills: take initiative and move forward with limited guidance. A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com Show more Show less

Summary In this role, he will drive a strategic AI transformation across the pharmaceutical value chain, from drug discovery to commercialization, by leading enterprise-wide initiatives and coaching sub-ordinates to deliver high-impact solutions. About the Role Major Accountabilities Domain Expertise: Serve as a strategic expert in life sciences, providing leadership in applying Generative AI to drug discovery, clinical trials, regulatory affairs, pharmacovigilance, and market access. Drive thought leadership by identifying and promoting innovative Generative AI applications to position the organization as an industry leader. Business Analysis: Lead enterprise-wide initiatives to gather, analyze, and prioritize business requirements, aligning AI solutions with long-term organizational objectives. Oversee comprehensive analyses of complex business processes, designing AI-driven strategies to achieve operational excellence and competitive advantage. Authorize and review business cases, feasibility studies, and ROI analyses to secure executive approval for transformative AI initiatives. Ensure the creation of high-quality business requirements documents, process flows, and strategic roadmaps to guide enterprise-level AI implementations. Stakeholder Engagement: Act as a key liaison between C-suite executives, technical teams, and external partners, driving alignment on AI strategies and initiatives. Lead enterprise-level workshops, steering committees, and governance boards to shape AI adoption and ensure stakeholder buy-in. Represent the organization in industry forums and partnerships to advocate for AI-driven innovation in life sciences. Team Management and Coaching: Manage/mentor a team of Senior Specialist Business Analysts, providing strategic guidance, setting performance goals, and fostering professional development to ensure high-impact AI business use case delivery. Coach Senior Specialists in advanced business analysis techniques and Generative AI applications, enhancing their ability to address complex challenges in the life sciences domain and ensuring alignment with organizational objectives. Generative AI: Oversee the development and deployment of enterprise-scale Generative AI solutions, ensuring alignment with business needs and technical feasibility.s Collaborate with AI architects and data science leaders to define model architectures and deployment frameworks for life sciences applications. Ensure AI solutions are scalable, reliable, and fully integrated into mission-critical workflows. Regulatory & Compliance: Establish governance frameworks to ensure AI solutions comply with global regulatory standards (e.g., USFDA, EU, PMDA) and ethical principles. Lead risk management efforts, addressing ethical, legal, and operational risks associated with AI deployment in life sciences. Minimum Requirements 10–12 years of core Business Analyst or strategic consulting experience in the life sciences domain with at least 5 years leading AI technologies, supported by a Master’s degree in Life Sciences, Biomedical Sciences, Computer Science, Data Science, or a related field. A PhD or MBA is highly desirable. Expert understanding of Generative AI, machine learning, and their applications in life sciences. Proficiency in advanced data analysis tools (e.g., Python, TensorFlow, Power BI). Exceptional project management skills, with a proven track record of leading enterprise-scale AI projects (e.g., Agile, SAFe, or PMI methodologies). Superior analytical and problem-solving abilities, with a strategic mindset and ability to drive organizational change. Outstanding communication and leadership skills, with the ability to influence C-level stakeholders and lead cross-functional teams. Deep familiarity with life sciences/pharmaceutical regulatory requirements and industry standards. Why consider Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Division Operations Business Unit Universal Hierarchy Node Location India Site Hyderabad (Office) Company / Legal Entity IN10 (FCRS = IN010) Novartis Healthcare Private Limited Functional Area Technology Transformation Job Type Full time Employment Type Regular Shift Work No

Summary In this role you will lead an impactful deliverable across the pharma value chain from drug discovery to commercialization by leveraging Indepth understanding in business process and Generative AI About the Role Major accountabilities: Domain Expertise: Possess a knowledge across the end-to-end pharmaceutical value chain, including drug discovery, preclinical and clinical trials, regulatory affairs, pharmacovigilance, technical operations (manufacturing, supply chain, and quality assurance), and commercial operations (market access, sales, and marketing), to lead AI-driven initiatives. Stay updated on advancements in Generative AI and their applications to optimize processes across the pharmaceutical value chain, from R&D to commercialization. Business Analysis: Partner with senior stakeholders across R&D, manufacturing, and commercial teams to gather, document, and analyse complex business requirements, ensuring alignment with strategic organizational goals. Conduct in-depth analyses of business processes across the E2E value chain, identifying opportunities for Generative AI to enhance efficiency, quality, and market competitiveness. Develop detailed business cases, feasibility studies, and cost-benefit analyses to prioritize AI initiatives in drug development, manufacturing optimization, and commercial strategies. Create comprehensive business requirements documents, process flow diagrams, and solution blueprints to guide AI implementation across the value chain. Stakeholder Engagement: Translate complex AI concepts into actionable insights for technical and non-technical stakeholders in R&D, technical operations, and commercial teams, securing buy-in and alignment. Facilitate workshops, strategy sessions, and cross-functional meetings to drive consensus on AI projects spanning discovery to commercialization. Mentor junior analysts to build team capability in AI-driven business analysis within the pharmaceutical value chain. Generative AI: Leverage Generative AI to analyse large, complex datasets across the value chain, uncovering patterns, trends, and insights for applications like drug candidate identification, manufacturing process optimization, and market demand forecasting. Collaborate with data scientists and AI engineers to design, develop, and deploy AI models tailored to specific needs in R&D, manufacturing, and commercial operations. Ensure AI solutions are interpretable, scalable, and integrated into workflows across the E2E value chain, from lab to market. Regulatory & Ethical Compliance: Ensure AI solutions comply with global regulatory requirements (e.g., USFDA, EU, PMDA) and ethical standards across all stages of the pharmaceutical value chain, including manufacturing and commercial activities. Identify and mitigate risks related to AI deployment, such as data privacy, model bias, and compliance with Good Manufacturing Practices (GMP). Minimum Requirements: Possess 6–8 years of core Business Analyst experience in the life sciences domain, with at least 3 years focused on AI technologies across the pharmaceutical value chain (R&D, manufacturing, and commercial operations), complemented by a master’s degree in Life Sciences, Biomedical Sciences, Computer Science, Data Science, or a related field. A PhD is a plus. Strong understanding of Generative AI, machine learning, and their applications in drug discovery, clinical trials, manufacturing, and commercial strategies. Proficiency in data analysis and visualization tools (e.g., Python, R, Tableau) to interpret complex datasets. Proven project management skills, with a track record of leading AI-related projects in at least one segment of the pharmaceutical value chain. Strong analytical and problem-solving abilities, with a strategic mindset and attention to detail. Exceptional communication and interpersonal skills, with the ability to mentor teams and influence stakeholders across R&D, technical operations, and commercial functions. Familiarity with pharmaceutical regulatory requirements (e.g., FDA, EMA, PMDA) and industry standards, including GMP and commercial compliance. Why consider Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Division Operations Business Unit Universal Hierarchy Node Location India Site Hyderabad (Office) Company / Legal Entity IN10 (FCRS = IN010) Novartis Healthcare Private Limited Functional Area Technology Transformation Job Type Full time Employment Type Regular Shift Work No

Job title: Sr. Specialist Quality Services (Product Complaints) Location: Hyderabad About the job Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines. Main responsibilities: Handle Product Technical Complaints (PTC) for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards. Collaborate with internal/external stakeholders viz Cross functional teams, Manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management departments for complaint management, Contract manufacturing organization. Enter complaints into the global database and evaluate complaints for severity and risk, ensure timely processing and closure of the complaints. Manages and ensures the compliance of all Quality processes and documentation with applicable regulations/ Sanofi standards. Handle QMS records & any discrepancies and ensure completion within defined timelines. Ensure investigation management and coordination with internal and external partners (including tracking and monitoring of investigations). Review & closure of investigation reports to ensure correctness, completeness, and adherence to standards including root cause analysis, CAPA, assessment and prioritization. Collection, visualization & analysis of complaint data. Preparation of trend reports of complaints related to products, sites, EMS & Countries defined as per procedure. About you: Experience: 3 - 7 Years Experience. Education: Graduate in Pharmacy or life sciences or Engineering or Biotechnology. Languages: English, Hindi is preferred Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks’ gender-neutral parental leave. Opportunity to work in an international environment, collaborating with diverse business teams and vendors, working in a dynamic team, and fully empowered to propose and implement innovative ideas. null

Job title: Scientific Sales Executive Location: Delhi Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally. Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com . PURPOSE OF THE ROLE To achieve the area sales objectives and stretch beyond targets by increasing prescription from identified doctors through effective implementation of marketing activities. To support in organizing patient acquisition and retention programs Internal CSM, RBM, Supply Chain Manager, Product Manager, Assistant Manager – HR (Sales),Zonal OPTIMA coordinator, Zonal Finance, Regional Training Manager External Distributors, Doctors, Chemists, Pharmacovigilance, Sales Director MANAGEMENT / LEADERSHIP RESPONSIBILITY 1.Organization To align with and participate actively in organization led initiatives periodically To understand and comply with the organization Code of Ethics 2.Scope of Role (Team, Geographical, Material) Role based at the respective region assigned KEY RESULT AREAS Work Area Descriptors Performance Indicators 1.People Capability Development - Attend all local and regional meetings and training programs and acquire and apply knowledge as disseminated through such programs. New Hire Induction - Impart field induction training to new joiners monitor progress and give feedback to superiors. Make product presentation and assist area manager in PCM’s whenever required. Assist CSM in collection and summarizing of SLP sales leadership in plan formats. Attendance and participation at local/regional meeting Attendance and participation in training programs/seminar 2.Financial Sales Target Achievement - Achieve monthly, quarterly and annual sales targets as assigned by CSM/RBM Inventory Management - Forwarding of breakage & expiry of products within limits of authority. Customer Acquisition Budget Management - Decide and effectively utilize financial investment for doctors within the ethical guidelines of the group. Target achieved % Growth 3.Process Efficient Day Planning - Plan day’s work with clear objectives for each call, perform pre and post call analysis and visits chemists for feedback. Market Intelligence - Keep track of movement of company products vis-à-vis competitor’s products and give regular feedback to superiors. Assist the CSM to identify appropriate target doctors. Report adverse events to Pharmacovigilance. Effective utilization of SFE tools OPTIMA and SLP guidelines for process excellence. Product Availability - Make the products available, follow-up and coordinate with the chemists and C&F to ensure adequate inventories of company’s products. Call average Frequency of coverage i.e. A & B Accuracy and timeliness of Data entered in OPTIMA Market & competitors feedback to superiors Adverse event reporting 4.Customer Brand Building - Organize specific group events of doctors – organize logistics e.g. venue, date, & time, materials, etc. and co-ordinate with executive/product manager in compliance with the ethical framework of the company. Participate in the patient acquisition and retention campaigns, where applicable. Give post program feedback; follow up with participating doctors to increase demand. Inventory level recording Quality, timeliness and effectiveness of events organized % growth in patient acquisition and retention Feedback from retailers, distributors ROLE – HOLDER ENTRY REQUIREMENTS Minimum Educational Qualification Any Graduate, preferably B.Sc or B.Pharma Relevant Work Experience Minimum years of experience 2+ years of relevant experience Preferred industry experience Pharmaceuticals, Consumer Health Care Functional Knowledge Required Product Knowledge Knowledge of pharma industry Basic Financial Management Knowledge Skills Required Excellent oral and verbal communication skills Basic use of MS Office Business Acumen and entrepreneurial traits Influencing and negotiation skills Desired Competencies Act for Change Think strategically Strive for Results Lead Teams Commit to Customers Make Decisions Cooperate Transversally Develop People CAREER DEVELOPMENT OPPORTUNITIES The career path for the role can be vertically towards the Channel Sales Manager role Why us? At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day. We Are Challengers. We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things: All In Together: We keep each other honest and have each other's backs. Courageous: We break boundaries and take thoughtful risks with creativity. Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity. Radically Simple: We strive to make things simple for us and simple for consumers, as it should be. Join us on our mission. Health. In your hands. www.opella.com/en/careers

Site Name: India - New Delhi Jai Singh Posted Date: Jun 6 2025 Job Purpose: Provide scientific and technical expertise of the highest standards for local medical information, including interactions with Key External Experts (KEEs) and Key Opinion Leaders (KOLs) Provide medical and scientific input and information for business strategy for the region. Key Responsibilities : Develop and sustain credible networking with appropriate Health Care Practitioners (HCPs) Plan, facilitate and conduct CMEs, symposia, trainings, workshops, scientific meetings, speaker tours, and other product specific campaigns and deliver scientific presentations with consistent messages for key products at these meetings, as required. Support and deliver scientific presentations with consistent “on label” messages at medical education meetings. Understand principles of and support Scientific Engagement (SE) activities as per Medical Plans. Have clarity in understanding on Scientific Engagements and Promotional Code. Become an expert in oncology where GSK have brands and support associated activities related to those brands. Be updated on scientific knowledge on oncology; GSK molecules and its PI to ensure its ‘On Label’ communications on various platforms. Support in feasibility assessment of potential research sites, develop concept notes, proposals, budgets, data collection and monitoring tools for field studies. Provide medical inputs into development and execution of brand strategy. Pharmacovigilance: Support Named Safety contact in strengthening of oncology Pharmacovigilance; ensure self-learning. Knowledge/ Education / Previous Experience Required A. Educational Background :- Minimum Level of Education - MBBS with post graduate qualification Preferred Level of Education - Post graduate qualification in Pharmacology / Public Health Why is this Level of Education Preferred - To interact with specialized HCPs B. Job-Related Experience:- Minimum Level of Job-Related Experience required Excellent written and oral communication skills in English, local language Experience of presenting scientific topics at different settings A sound understanding of the principles and practice of ICH-GCP and internal SOPs. Well-demonstrated ability to understand scientific methods and experimental design. 1-2 years in the pharmaceutical industry preferably in the oncology therapy area. C. Other Job-Related Skills/Background:- General Competencies Presentation skills at Scientific meetings Communication skills, both verbal and written Technical writing skills Keep up to date with new developments Ability to provide and receive constructive feedback Build and maintain relationships with colleagues Share knowledge with other team members Work as part of a team to reach common goals Deliver creative ideas for continuous improvement Develop good relationships with key opinion leaders Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way. GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable. If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.

Job Title: Associate Medical Director, Patient Safety Physician Global Career Level: E Introduction to role: Are you ready to make bold moves in the field of oncology? As an Associate Medical Director, Patient Safety Physician, you will play a pivotal role in transforming the way cancer is treated. You will work independently or alongside senior safety physicians to evaluate adverse events and manage the safety profile of marketed products. Your expertise will be crucial in authoring regulatory documents and predicting the clinical implications of safety data. Join us in pushing the boundaries of science and making a meaningful difference in patients' lives! Accountabilities: As an Associate Medical Director, Patient Safety Physician, you will be responsible for signal detection, evaluation risk management activities, and labeling. You will provide medical input into the identification and utilization of information sources for signal evaluation, collaborate with external providers, and discuss data evaluation results with key stakeholders. Your strategic input will be vital in regulatory requests and safety evaluation documents. Additionally, you will contribute to regulatory reports and submissions, participate in external meetings, and maintain readiness for audits or inspections. Your collaboration across functions and cultures will drive innovation and process improvement. Essential Skills/Experience: Medical degree (eg MD, MBBS) At least 2 years of clinical experience post-registration High level of medical competence, with an ability to balance this with industry standards to achieve business goals Minimum 3 years of Patient Safety experience (Pharmacovigilance) (with clear evidence of delivery) Total of 6 to 11 years of experience Desirable Skills/Experience: Able to work across TAs and Functions Experience of supervising Patient Safety colleagues A demonstrated ability to understand epidemiological data Skills and Capabilities: Commitment to Customers and Integrity Strategic Leadership Acts Decisively Drives Accountability Works Collaboratively Develops People and Organisation May train or mentor junior level staff within given role Technical: Drug Development Experience and Application of Disease and TA knowledge Integrative thinking Excellence in pharmacovigilance Patient Benefit risk assessment Core: Conceptual thinking Influencing Initiative Innovation Business relationship management When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, you'll be part of a global team dedicated to eliminating cancer as a cause of death. With one of the broadest oncology pipelines in the industry, you'll have the opportunity to work on groundbreaking drug modalities and innovative approaches. Our collaborative environment fosters courage and curiosity, empowering you to take smart risks and challenge the norm. We are committed to making a meaningful impact on patients' lives through science-driven solutions. Ready to make a difference? Apply now and join us on our mission to transform cancer treatment!

Job title: Scientific Sales Executive Location: Kurnool Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally. Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com. PURPOSE OF THE ROLE To achieve the area sales objectives and stretch beyond targets by increasing prescription from identified doctors through effective implementation of marketing activities. To support in organizing patient acquisition and retention programs Internal CSM, RBM, Supply Chain Manager, Product Manager, Assistant Manager – HR (Sales),Zonal OPTIMA coordinator, Zonal Finance, Regional Training Manager External Distributors, Doctors, Chemists, Pharmacovigilance, Sales Director MANAGEMENT / LEADERSHIP RESPONSIBILITY 1.Organization To align with and participate actively in organization led initiatives periodically To understand and comply with the organization Code of Ethics 2.Scope of Role (Team, Geographical, Material) Role based at the respective region assigned KEY RESULT AREAS Work Area Descriptors Performance Indicators 1.People Capability Development - Attend all local and regional meetings and training programs and acquire and apply knowledge as disseminated through such programs. New Hire Induction - Impart field induction training to new joiners monitor progress and give feedback to superiors. Make product presentation and assist area manager in PCM’s whenever required. Assist CSM in collection and summarizing of SLP sales leadership in plan formats. Attendance and participation at local/regional meeting Attendance and participation in training programs/seminar 2.Financial Sales Target Achievement - Achieve monthly, quarterly and annual sales targets as assigned by CSM/RBM Inventory Management - Forwarding of breakage & expiry of products within limits of authority. Customer Acquisition Budget Management - Decide and effectively utilize financial investment for doctors within the ethical guidelines of the group. Target achieved % Growth 3.Process Efficient Day Planning - Plan day’s work with clear objectives for each call, perform pre and post call analysis and visits chemists for feedback. Market Intelligence - Keep track of movement of company products vis-à-vis competitor’s products and give regular feedback to superiors. Assist the CSM to identify appropriate target doctors. Report adverse events to Pharmacovigilance. Effective utilization of SFE tools OPTIMA and SLP guidelines for process excellence. Product Availability - Make the products available, follow-up and coordinate with the chemists and C&F to ensure adequate inventories of company’s products. Call average Frequency of coverage i.e. A & B Accuracy and timeliness of Data entered in OPTIMA Market & competitors feedback to superiors Adverse event reporting 4.Customer Brand Building - Organize specific group events of doctors – organize logistics e.g. venue, date, & time, materials, etc. and co-ordinate with executive/product manager in compliance with the ethical framework of the company. Participate in the patient acquisition and retention campaigns, where applicable. Give post program feedback; follow up with participating doctors to increase demand. Inventory level recording Quality, timeliness and effectiveness of events organized % growth in patient acquisition and retention Feedback from retailers, distributors ROLE – HOLDER ENTRY REQUIREMENTS Minimum Educational Qualification Any Graduate, preferably B.Sc or B.Pharma Relevant Work Experience Minimum years of experience 2+ years of relevant experience Preferred industry experience Pharmaceuticals, Consumer Health Care Functional Knowledge Required Product Knowledge Knowledge of pharma industry Basic Financial Management Knowledge Skills Required Excellent oral and verbal communication skills Basic use of MS Office Business Acumen and entrepreneurial traits Influencing and negotiation skills Desired Competencies Act for Change Think strategically Strive for Results Lead Teams Commit to Customers Make Decisions Cooperate Transversally Develop People CAREER DEVELOPMENT OPPORTUNITIES The career path for the role can be vertically towards the Channel Sales Manager role Why us? At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day. We Are Challengers. We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things: All In Together: We keep each other honest and have each other's backs. Courageous: We break boundaries and take thoughtful risks with creativity. Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity. Radically Simple: We strive to make things simple for us and simple for consumers, as it should be. Join us on our mission. Health. In your hands. www.opella.com/en/careers

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Job Summary: Responsible for the execution of operational tasks and all aspects of technical delivery and project management in the field of Literature Screening. Key Responsibilities: Responsible for quality management, workload management, compliance management and document management for the assigned PV projects. Manages project coordination and resource allocation within the projects. Train and mentor PV department staff, as needed. Ensure monthly invoices are generated and shared for all PV clients on regular/monthly basis. Responsible for recruitment of new staff in PV Department. Is involved in objective setting and annual appraisals of staff. Ensures training compliance for PV staff Represents PV department during for-cause/maintenance client audits or regulatory authority inspections. To write/ review QA documents such as SDEA’s, Working Instructions, SOPs, Working Procedures, templates, project metafiles etc. for PharmaLex Pharmacovigilance projects. To organize and perform training of the above-mentioned documents. Identification (Classification of references) of safety- relevant publications in the scientific literature. Provision of scientific input during literature surveillance service. Screening scientific literature by using the internal search mechanism and/or by making use of external tools and providers. Medical assessment of literature reports into the safety database. Act as main contact for client/project management. The employee agrees to take over primary listed tasks and responsibilities in other service lines and additional reasonable tasks that align with their abilities, qualification and training, if required. . Qualifications Master’s/Bachelor’s degree in Pharmacy, Medicine, or a related field. Advanced degree preferred. Minimum of 6-9 years of experience in pharmacovigilance. Experience in handling pharmacovigilance activities for multiple countries. Excellent communication and interpersonal skills with special focus on Quality Ability to work effectively in a multicultural environment. Well versed with pharmacovigilance regulations and guidelines and updated with the latest developments in regulatory guidelines? Strong analytical and problem-solving skills. What Cencora offers Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements. Full time Affiliated Companies Affiliated Companies: PharmaLex India Private Limited Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned