1738 Pharmacovigilance Jobs - Page 25

Job Description Regional Medical Advisor (RMA) – General & Specialty Medicine, South Region The RMA will serve as a key representative for our company, engaging with essential stakeholders in the field. The objective of our medical affairs team is to provide scientific expertise across identified regions, products, and therapy areas to these valued customers. Responsibilities And Primary Activities Scientific Expertise Develop and maintain a comprehensive understanding of the company's products, particularly in the cardiovascular therapeutic area, while staying updated on the latest medical advancements, clinical guidelines, and treatment protocols. Stakeholder Engagement Build and maintain relationships with Scientific Leaders (SLs), Key Decision Makers (KDMs), healthcare professionals, and academic institutions. Engage in scientific discussions, present clinical data, and provide educational support to Key Opinion Leaders (KOLs) regarding the company's products and therapeutic areas. Support to Medical Strategy Collaborate with the line manager to provide strategic inputs and expertise to product management. Medical Education Deliver scientific and medical education to internal stakeholders, including sales and marketing teams. Collaborate with the Medical Affairs team to develop and present training materials. Scientific Exchange Facilitate knowledge transfer between the company and external stakeholders by participating in medical conferences, advisory boards, and scientific meetings to gather insights and share data. Clinical Data Communication Interpret and communicate clinical trial data, real-world evidence, and other scientific information to healthcare professionals and regulators, ensuring compliance with regulations and company policies. Clinical Research Support Provide medical support for local studies, including identifying study sites for Investigator Initiated Trials. Cross-Functional Collaboration Work closely with Clinical Development, Regulatory Affairs, Marketing, and Market Access teams to provide scientific input, support clinical trial design, and align on medical communication plans. Medical Initiatives Support and lead medical projects aligned with the therapy area, involving strong stakeholder interaction. Medical Information Address medical inquiries and provide timely, accurate responses to healthcare professionals and other stakeholders, ensuring that medical information materials are current and compliant. Sales Force Training Train sales colleagues on assigned therapy areas and assist in pre-launch and launch training for new products. Compliance Adhere to legal, regulatory, and compliance guidelines, ensuring all activities are conducted ethically and in accordance with applicable laws. Overall, the RMA in Medical Affairs acts as a scientific expert and liaison between the company and external stakeholders, playing a crucial role in building scientific credibility, fostering relationships, and supporting the company's strategic objectives in the healthcare industry. Values and Behaviours Consistently demonstrate company values with a focus on excellence. Collaborate harmoniously with internal and external stakeholders. What You Must Have Educational Background A strong academic foundation in life sciences, such as a medical degree (MD) or doctorate (Ph.D.). Industry Experience At least 1 year of experience in the pharmaceutical cardiovascular therapy area, including roles in clinical research or medical affairs that expose the candidate to scientific and medical aspects of the industry. Therapeutic Area Expertise Demonstrated knowledge and expertise in the relevant cardiovascular therapeutic area, including experience with clinical trials and publications. Scientific and Clinical Knowledge Strong understanding of medical and scientific principles, including clinical trial design, data analysis, and interpretation, along with familiarity with relevant disease states and treatment guidelines. Communication and Relationship-Building Skills Excellent interpersonal, communication, and presentation skills are essential for effectively conveying scientific information to various stakeholders. Analytical and Problem-Solving Skills Ability to analyse complex scientific data, identify insights, and provide recommendations, particularly in interpreting clinical trial results and addressing medical inquiries. Adaptability and Flexibility Capability to work in dynamic environments, adapt to changing priorities, and travel frequently to engage with external stakeholders. Regulatory and Compliance Knowledge Familiarity with legal, regulatory, and compliance guidelines, including Good Clinical Practice (GCP) and ICH guidelines, as well as local regulations governing medical communications. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Not Applicable Shift Valid Driving License Hazardous Material(s) Required Skills Advisory Board Development, Advisory Board Development, Clinical Development, Clinical Knowledge, Clinical Testing, Educational Program Development, Emergency Care, Good Clinical Practice (GCP), Healthcare Education, Health Economics Research, Investigator-Initiated Studies (IIS), Life Science, Management Process, Medical Affairs, Medical Communications, Medical Information Systems, Medical Marketing Strategy, Medical Policy Development, Medical Writing, Pharmacovigilance, Product Knowledge, Product Management, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Compliance Consulting {+ 5 more} Preferred Skills Job Posting End Date 08/31/2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R350739

Job Description Regional Medical Advisor (RMA) – General & Specialty Medicine, North Region The RMA will serve as a key representative for our company, engaging with essential stakeholders in the field. The objective of our medical affairs team is to provide scientific expertise across identified regions, products, and therapy areas to these valued customers. Responsibilities And Primary Activities Scientific Expertise Develop and maintain a comprehensive understanding of the company's products, particularly in the cardiovascular therapeutic area, while staying updated on the latest medical advancements, clinical guidelines, and treatment protocols. Stakeholder Engagement Build and maintain relationships with Scientific Leaders (SLs), Key Decision Makers (KDMs), healthcare professionals, and academic institutions. Engage in scientific discussions, present clinical data, and provide educational support to Key Opinion Leaders (KOLs) regarding the company's products and therapeutic areas. Support to Medical Strategy Collaborate with the line manager to provide strategic inputs and expertise to product management. Medical Education Deliver scientific and medical education to internal stakeholders, including sales and marketing teams. Collaborate with the Medical Affairs team to develop and present training materials. Scientific Exchange Facilitate knowledge transfer between the company and external stakeholders by participating in medical conferences, advisory boards, and scientific meetings to gather insights and share data. Clinical Data Communication Interpret and communicate clinical trial data, real-world evidence, and other scientific information to healthcare professionals and regulators, ensuring compliance with regulations and company policies. Clinical Research Support Provide medical support for local studies, including identifying study sites for Investigator Initiated Trials. Cross-Functional Collaboration Work closely with Clinical Development, Regulatory Affairs, Marketing, and Market Access teams to provide scientific input, support clinical trial design, and align on medical communication plans. Medical Initiatives Support and lead medical projects aligned with the therapy area, involving strong stakeholder interaction. Medical Information Address medical inquiries and provide timely, accurate responses to healthcare professionals and other stakeholders, ensuring that medical information materials are current and compliant. Sales Force Training Train sales colleagues on assigned therapy areas and assist in pre-launch and launch training for new products. Compliance Adhere to legal, regulatory, and compliance guidelines, ensuring all activities are conducted ethically and in accordance with applicable laws. Overall, the RMA in Medical Affairs acts as a scientific expert and liaison between the company and external stakeholders, playing a crucial role in building scientific credibility, fostering relationships, and supporting the company's strategic objectives in the healthcare industry. Values and Behaviours Consistently demonstrate company values with a focus on excellence. Collaborate harmoniously with internal and external stakeholders. What You Must Have Educational Background A strong academic foundation in life sciences, such as a medical degree (MD) or doctorate (Ph.D.). Industry Experience At least 1 year of experience in the pharmaceutical cardiovascular therapy area, including roles in clinical research or medical affairs that expose the candidate to scientific and medical aspects of the industry. Therapeutic Area Expertise Demonstrated knowledge and expertise in the relevant cardiovascular therapeutic area, including experience with clinical trials and publications. Scientific and Clinical Knowledge Strong understanding of medical and scientific principles, including clinical trial design, data analysis, and interpretation, along with familiarity with relevant disease states and treatment guidelines. Communication and Relationship-Building Skills Excellent interpersonal, communication, and presentation skills are essential for effectively conveying scientific information to various stakeholders. Analytical and Problem-Solving Skills Ability to analyse complex scientific data, identify insights, and provide recommendations, particularly in interpreting clinical trial results and addressing medical inquiries. Adaptability and Flexibility Capability to work in dynamic environments, adapt to changing priorities, and travel frequently to engage with external stakeholders. Regulatory and Compliance Knowledge Familiarity with legal, regulatory, and compliance guidelines, including Good Clinical Practice (GCP) and ICH guidelines, as well as local regulations governing medical communications. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Not Applicable Shift Valid Driving License Hazardous Material(s) Required Skills Advisory Board Development, Advisory Board Development, Clinical Development, Clinical Knowledge, Clinical Testing, Educational Program Development, Emergency Care, Good Clinical Practice (GCP), Healthcare Education, Health Economics Research, Investigator-Initiated Studies (IIS), Life Science, Management Process, Medical Affairs, Medical Communications, Medical Information Systems, Medical Marketing Strategy, Medical Policy Development, Medical Writing, Pharmacovigilance, Product Knowledge, Product Management, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Compliance Consulting {+ 5 more} Preferred Skills Job Posting End Date 08/31/2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R350735

Job Overview Individual contributor with advanced knowledge acquired from several years of experience in the professional discipline. Works independently under limited supervision. Essential Functions Acts as a Regulatory Team Leader on complex projects, which may include technical writing and/or may act as a Project Manager for a stand-alone project, with guidance from senior staff as appropriate; Competently writes regulatory and/or technical documents with minimal review by senior staff; Establishes relationships with many customers; may meet face to face without rest of team to discuss regulatory issues and present lessons learned. Adopts a proactive and flexible approach to resolve any issues; Undertakes detailed review and management of budgets related to projects, including out of scope activities. Ensures revenue is recognised and challenges when appropriate, may seek guidance from senior staff as appropriate; May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development; May present to clients at bid defense meetings by phone or in person, for a range of regulatory deliverables, at discretion of senior staff; May write new regulatory standard operating procedures, and/or propose revisions and/or act as reviewer for regulatory standard operating procedures, as assigned and appropriate. May be involved in a Regulatory and/or IQVIA Initiative; Performs other tasks or assignments, as delegated by Regulatory management; May manage meetings with Regulatory Agencies; May be assigned as Reviewer and/or Approver for Regulatory standard operating porcedures or cross-functional standard operating porcedures owned by other operations; May support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative; Performs other duties, as business needs require; Qualifications Bachelor's Degree Degree in Lifescience or related discipline Req Or Master's Degree Degree in Lifescience or related discipline At least 8 years relevant experience Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate; Possesses a specific regulatory or technical expertise. Sufficient knowledge of managing regulatory projects, project deliverables on a time bound manner; Expert in planning and delivering work on time keeping quality parameter in mind; Knowledge of regulatory procedures in appropriate region – particularly marketing authorization transfers and relevant cross-functional dependencies; Good working knowledge of regional regulatory intelligence; Ability to work closely with client regional heads to determine the MAT, Regulatory Publishing & submission strategy and execute marketing authorization transfer plan, if applicable; Good understanding of pharmacovigilance activities relevant to transfer of marketing authorization; Ability to establish and maintain effective working relationships with coworkers, managers and clients; Strong software and computer skills, including Microsoft Office, publishing applications and tools, as applicable; Ability to work on several projects, with direction from senior staff as appropriate; Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements; Ability to make decisions on discrete tasks under senior supervision; Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education; Experience of involvement in regulatory strategy and determination of documentation requirements, timelines, budgets for MATs, Publishing projects; Project leadership experience; Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area; Problems faced are general and may require understanding of broader set of issues, but typically are not complex; Ability to adapt quickly to a rapidly changing environment; Applicable certifications and licenses as required by country, state, and/or other regulatory bodies 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

Write and/or edit high-quality scientific response documents independently under the direction of the Global Medical Information (GMI) team in support of global and local medical information activities. Research and authors response documents, reviews compendia, and prepares US FDA Annual reports with minimal guidance, acting as an SME on different types of response documents and other GMI activities. Proficient understanding of Medical Information achieved through a combination of product knowledge, along with editing, writing, and document management. Essential Job duties and responsibilities: 1 ) Proficient in Conducting literature searches and reviews; and extracting/ summarizing complex data from the scientific literature. 2 ) Works with minimal guidance to generate evidence-based, accurate, current, and fair-balanced summaries of data for the creation/maintenance of scientific response documents for products in multiple therapeutic areas, develops US FDA Annual Reports, and reviews compendia . 3) Ability to produce medical documents according to all Sanofi relevant global guidelines, country guidelines and policies. 4 ) Acts as a Subject Matter Expert maintaining expertise in the processes, templates, and guidelines, and key deliverables aligned with the key trends and developments in the industry. 5 ) Constantly assist other medical information writers in developing knowledge and sharing expertise (on key deliverables, processes, templates, and guidelines). 6) Agile and knowledgeable to be able to work across different therapeutic areas and new deliverable types. 7) Demonstrates resolve and urgency to accomplish tasks and liaise with cross-functional project teams as needed. 8) Ensure that assigned projects are completed on schedule. 9) Demonstrates a deep understanding and/or experience of working in a regulated GXP environment People: 1) Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product - with an end objective to develop medical information content as per requirement. 2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly assist other medical information writers in developing knowledge and sharing expertise. Performance: 1) Provide SME support and high-quality completion of deliverables (local and custom scientific response documents, US FDA Annual Reports, and Compendia Reviews) as per agreed timelines and quality. 2) Supports delivery of projects in terms of resourcing, quality, timeliness, efficiency, and high technical standards with the agility to learn and contribute to situations of demands. 3) Ability to multi task and manage different type of projects simultaneously. Process: 1) Act as an expert in the field of medical information writing with project management skills and maintain the regulatory requirement for countries supported. 2) Assist the assigned medical information team in conducting comprehensive medical writing needs analysis. 3) Implement relevant elements of content plans and associated activities for the year identified for the assigned countries. 4) Work with selected vendors within the region to deliver the required deliverables as per the defined process. 5) Design an overall plan of action basis end-customers feedback & improve course content and delivery. 6) Capable of identifying risks to processes and proposing mitigation plans through the application of a problem-solving mindset. Stakeholders: 1) Work closely with medical teams in countries/regions/areas to identify medical writing needs and assist in developing assigned deliverables. 2) Liaise with the Medical department to prepare relevant & customized deliverables. 3) Collaborate with the Global Medical Information team and country medical information teams as relevant. About you Soft skills : Excellent communication skills (written, verbal, and presentation), Stakeholder management; and ability to work independently and within a team environment. Technical skills : As applicable (Including but not limited to Expert knowledge of medical information documents including Response documents, Compendia review and FDA Annual Reports, Medical operational excellence, time, and risk management skills, Excellent technical (medical) editing and writing skills, Knowledge about literature evaluation and multilevel response development). Understanding of the local country legal requirements with regards to Medical Information document provision for customers including health care professionals, patients, carers and other relevant decision makers (such as ABPI Code of Practice for UK) is desirable. Education : Advanced degree in life sciences/pharmacy/similar discipline (Ph.D., Master, or bachelor s in science, D Pharms) or medical degree (MBBS, BDS, BAMS, BHMS, MD) Languages : Excellent knowledge of the English language (spoken and written)

Job Summary We are seeking a highly skilled General Manager-CDM/PV with 8 to 10 years of experience in Pharma Research & Development. The ideal candidate will have expertise in PV Case Processing Pharmacovigilance and Safety Operations. This hybrid role offers the opportunity to work in a dynamic environment contributing to the safety and efficacy of pharmaceutical products. Responsibilities Lead the pharmacovigilance team to ensure compliance with regulatory requirements and company policies. Oversee the processing of PV cases ensuring accuracy and timeliness in reporting. Provide strategic direction for safety operations aligning with organizational goals. Collaborate with cross-functional teams to enhance pharmacovigilance processes and systems. Monitor and analyze safety data to identify trends and potential risks. Develop and implement risk management plans to mitigate identified safety concerns. Ensure the effective documentation and reporting of adverse events. Conduct regular audits and inspections to maintain high standards of compliance. Train and mentor team members on best practices in pharmacovigilance and safety operations. Coordinate with regulatory authorities to ensure timely submission of safety reports. Drive continuous improvement initiatives to enhance the efficiency of PV processes. Manage the budget and resources for the pharmacovigilance department. Foster a culture of safety and compliance within the organization. Qualifications Possess a strong background in Pharma Research & Development with at least 8 years of experience. Demonstrate expertise in PV Case Processing and Pharmacovigilance. Have a solid understanding of safety operations and regulatory requirements. Exhibit excellent leadership and team management skills. Show proficiency in data analysis and risk management. Have experience in conducting audits and ensuring compliance. Be adept at collaborating with cross-functional teams. Possess strong communication and training skills. Demonstrate the ability to drive continuous improvement initiatives. Be capable of managing budgets and resources effectively. Show a commitment to fostering a culture of safety and compliance. Have a proactive approach to identifying and mitigating risks. Be detail-oriented with strong organizational skills. Certifications Required Certified Pharmacovigilance Professional (CPP) or equivalent certification.

PVASC Author: Demonstrates a good understanding with regards to how Business Development, Commercial and Legal teams operate Demonstrates technical expertise in interpretation of PV regulations, SOP/GUIs, systems/database conventions, etc. Responsible for co-ordination, end to end evaluation, negotiation, and delivery of Pharmacovigilance Agreements & Safety Clauses (PVASC) with Third Parties to ensure GSK can meet its drug safety and vigilance obligations and ensure Patient Safety Responsible for leading internal projects relevant to PVASCs, change management and making significant contributions to enable or improve compliance with global regulatory requirements for drug safety and vigilance Manage end to end PVASC activities with business partners. These activities include without limitation: Initiates, negotiates and revises PVASCs as required Accountable for collaborating with business development, legal and licensing partners to negotiate and ensure PVASCs are maintained per GSK policy and procedure Collaborates with the heads of various departments to support PV operational needs when implementing obligations from a PVASC or company integration Acts as the primary Third-Party collaboration contact on all matters relating to PVASCs for internal and external stakeholders Performs due diligence of Third Parties vigilance systems prior to PVASC negotiation Ensures compliance with worldwide PV, materiovigilance regulations, guidelines and industry practice Conducts routine reviews of PVASCs to ensure adherence with global requirements, GSK business practices and the terms/status of the commercial agreement In depth knowledge of GCP, clinical safety documentation and reporting of adverse events from clinical trials, local regulatory requirements, and pharmacovigilance methodology; general understanding of worldwide regulatory requirements. Implement, maintain, and improve processes in alignment with GSK policy to ensure that PVASCs are maintained throughout their lifecycle and to ensure that GSK and partners comply with the terms of executed agreements. Ensure stakeholders in LOCs, clinical, business development, quality and other relevant groups understand and are aware of their obligations for PVASCs PVASC Leadership Responsibilities: Demonstrated project management skills operating in a global matrix environment Providing respective team support consistently, efficiently and reliably delivering to regulatory requirements, third party commitments (implementation, maintenance and termination of PVASC) and organizational expectations and driving quality across the team. Ensure team support is provided for consistently, efficiently and reliably delivering to regulatory requirements, third party commitments (implementation, maintenance and termination of PVASC) and organizational expectations and driving quality across the team. Developing and sharing pharmacovigilance and technical knowledge and experience with team members Identify cases of potential noncompliance with internal and external procedures and follow appropriate procedures to investigate and, where necessary, identify risks, appropriate corrective actions and prevent future issues Participate in quality or continuous process improvement activities related to area of responsibility or as requested Maintain good documentation practice and be the Point of Contact in case of inspection/audit. Provide inputs and support to site head in meeting the high-level objectives and assist in designing vision for the team. Accountable Safety and Pharmacovigilance Agreements (PVA) databases Accountable for managing and tracking PVASC agreements and reporting KPI status against PVASCs periodically to Management Deliver training and/or project support as required Implement, maintain and improve processes in alignment with GSK policy to ensure that PVASCs are maintained throughout their lifecycle and to ensure that GSK and partners comply with the terms of executed agreements. Delivering training and/or project support as required Balance resource requirements across the portfolio and promote a pragmatic, flexible, focused approach to workload Develop and share technical, pharmacovigilance, PVASC and PV systems knowledge and experience with team members Aid in Inspections/Audit. Constructing root cause analysis for the findings, non-conformities and CAPA for the same Aid team members with decision-making, problem solving and work prioritization; provide review and quality check support as required Lead in quality or continuous process improvement activities related to area of responsibility or as requested Maintain appropriate organizational networks Recognize matters that affect corporate or agency policies and escalate issues with high business impact or risk. Important notice to Employment businesses/ Agencies

Write and/or edit high-quality scientific response documents independently under the direction of the Global Medical Information (GMI) team in support of global and local medical information activities. Research and authors response documents, reviews compendia, and prepares US FDA Annual reports with minimal guidance, acting as an SME on different types of response documents and other GMI activities. Proficient understanding of Medical Information achieved through a combination of product knowledge, along with editing, writing, and document management. Essential Job duties and responsibilities: 1 ) Proficient in Conducting literature searches and reviews; and extracting/ summarizing complex data from the scientific literature. 2 ) Works with minimal guidance to generate evidence-based, accurate, current, and fair-balanced summaries of data for the creation/maintenance of scientific response documents for products in multiple therapeutic areas, develops US FDA Annual Reports, and reviews compendia . 3) Ability to produce medical documents according to all Sanofi relevant global guidelines, country guidelines and policies. 4 ) Acts as a Subject Matter Expert maintaining expertise in the processes, templates, and guidelines, and key deliverables aligned with the key trends and developments in the industry. 5 ) Constantly assist other medical information writers in developing knowledge and sharing expertise (on key deliverables, processes, templates, and guidelines). 6) Agile and knowledgeable to be able to work across different therapeutic areas and new deliverable types. 7) Demonstrates resolve and urgency to accomplish tasks and liaise with cross-functional project teams as needed. 8) Ensure that assigned projects are completed on schedule. 9) Demonstrates a deep understanding and/or experience of working in a regulated GXP environment People: 1) Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product – with an end objective to develop medical information content as per requirement. 2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly assist other medical information writers in developing knowledge and sharing expertise. Performance: 1) Provide SME support and high-quality completion of deliverables (local and custom scientific response documents, US FDA Annual Reports, and Compendia Reviews) as per agreed timelines and quality. 2) Supports delivery of projects in terms of resourcing, quality, timeliness, efficiency, and high technical standards with the agility to learn and contribute to situations of demands. 3) Ability to multi task and manage different type of projects simultaneously. Process: 1) Act as an expert in the field of medical information writing with project management skills and maintain the regulatory requirement for countries supported. 2) Assist the assigned medical information team in conducting comprehensive medical writing needs analysis. 3) Implement relevant elements of content plans and associated activities for the year identified for the assigned countries. 4) Work with selected vendors within the region to deliver the required deliverables as per the defined process. 5) Design an overall plan of action basis end-customers feedback & improve course content and delivery. 6) Capable of identifying risks to processes and proposing mitigation plans through the application of a problem-solving mindset. Stakeholders: 1) Work closely with medical teams in countries/regions/areas to identify medical writing needs and assist in developing assigned deliverables. 2) Liaise with the Medical department to prepare relevant & customized deliverables. 3) Collaborate with the Global Medical Information team and country medical information teams as relevant. About you Soft skills : Excellent communication skills (written, verbal, and presentation), Stakeholder management; and ability to work independently and within a team environment. Technical skills : As applicable (Including but not limited to Expert knowledge of medical information documents including Response documents, Compendia review and FDA Annual Reports, Medical operational excellence, time, and risk management skills, Excellent technical (medical) editing and writing skills, Knowledge about literature evaluation and multilevel response development). Understanding of the local country legal requirements with regards to Medical Information document provision for customers including health care professionals, patients, carers and other relevant decision makers (such as ABPI Code of Practice for UK) is desirable. Education : Advanced degree in life sciences/pharmacy/similar discipline (Ph.D., Master, or bachelor’s in science, D Pharms) or medical degree (MBBS, BDS, BAMS, BHMS, MD) Languages : Excellent knowledge of the English language (spoken and written)

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Pharmacy,BSc. Nursing,Bachelor of Physiotheraphy Years of Experience: 1 to 2 year About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. What are we looking for? Looking for the candidate with Good Communication and written skills, Bachelor of Pharmacy,Bachelor of Physiotheraphy,BSc. Nursing Roles and Responsibilities: n this role you are required to solve routine problems, largely through precedent and referral to general guidelines,Your expected interactions are within your own team and direct supervisor. You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments Bachelor of Pharmacy,BSc. Nursing,Bachelor of Physiotheraphy

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Pharmacy/Bachelor of Physiotheraphy/BSc. Nursing Years of Experience: 0 to 1 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? •Adaptable and flexible •Agility for quick learning •Ability to work well in a team Roles and Responsibilities: •In this role you are required to solve routine problems, largely through precedent and referral to general guidelines • Your primary interaction is within your own team and your direct supervisor • In this role you will be given detailed instructions on all tasks • The decisions that you make impact your own work and are closely supervised • You will be an individual contributor as a part of a team with a predetermined, narrow scope of work • Please note that this role may require you to work in rotational shifts Bachelor of Pharmacy,Bachelor of Physiotheraphy,BSc. Nursing

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Pharmacy/Bachelor of Physiotheraphy/BSc. Nursing Years of Experience: 0 to 1 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Adaptable and flexible Agility for quick learning Ability to work well in a team Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts

Position: Senior Safety Database Specialist (Argus/ArisG) Location : Chandigarh Job Type: Full Time (On-Site) Our Client is a contract research organization offering Pharmacovigilance, Regulatory, Evidence Evaluation and Technology Solutions, which are phase dependent. These verticals cover planning, launch and lifecycle management of Pharmaceutical, Consumer products and Medical devices. We are based out of Chandigarh and are currently hiring for our Regulatory affairs team. Basic Function: We are seeking an experienced Safety Database Specialist like Argus, ArisG and SafetyEasy to manage critical pharmacovigilance data workflows and ensure regulatory compliance. You will work on advanced Safety Database platform configurations, manage case processing accuracy, and support global PV operations across different pharmaceutical clients. Functional Responsibilities • Configure, maintain and manage the Safety Database with high data quality and accuracy. • Administer user roles, permissions, and access controls in compliance with data privacy and regulatory requirements. • Coordinate and implement system upgrades, patches, and hotfixes in collaboration with IT and vendor teams. • Manage integration of safety databases with other systems such as E2B (R2/R3) gateways, signal detection tools, or document management systems. • Support periodic system validation, including authoring/review of validation documents (URS, FRS, IQ/OQ/PQ). • Ensure compliance with global regulatory requirements (e.g., EMA, FDA, PMDA) and standards such as 21 CFR Part 11 and EU Annex 11. • Provide end-user training and system support to case processors, medical reviewers, and QA personnel. • Participate in safety database migrations and data reconciliation projects during system transitions or audits. Job Description • Maintain documentation and audit trails, and support internal/external audits and regulatory inspections. • Generate metrics and compliance dashboards related to case processing timelines, system performance, and data quality indicators. • Liaise with database vendors (e.g., Argus) for issue resolution, enhancements, and service requests. • Draft and maintain SOPs, work instructions, and user manuals related to the safety database operations. • Troubleshoot system issues and participate in validation activities. • Collaborate with cross-functional teams and stay up-to-date on regulations. Qualifications and Experience: • Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or a related field. • 7–10 Years in Pharmacovigilance with expertise in Safety Databases • Hands-on experience with Oracle Argus Safety (latest versions) and/or other PV databases such as ArisG, SafetyEasy, VigiFlow, LSMV. • Experience with case processing workflows, E2B (R2/R3) compliance, and electronic submissions. • Proficiency in MedDRA and WHO Drug Dictionary coding standards. • Familiarity with SQL, XML, and data query tools for ad-hoc data retrieval and troubleshooting. • Exposure to safety database upgrades, patch installations, and configuration management. • Experience in system integration with document management systems, signal detection tools, or reporting platforms (e.g., Power BI, Spotfire). • Strong understanding of global PV regulations and guidelines (ICH E2B, E2D, GVP Modules, 21 CFR Part 11, EU Annex 11). • Experience in preparing for and supporting audits and inspections . • Knowledge of GxP practices, validation principles (CSV), and system lifecycle documentation (URS, FRS, IQ/OQ/PQ). • Ability to identify and resolve database/system issues with root cause analysis. • Good verbal and written communication skills to interact with cross-functional teams (PV, QA, IT, Vendors). • Strong documentation and SOP adherence skills

Position/Job Role: Regulatory Submission Specialist Location: Chandigarh Job Type: Full Time (On-site) Job Overview We are seeking a highly skilled and detail-oriented Submission Expert specializing in Individual Case Safety Reports (ICSR) and aggregate report submissions to join our Pharmacovigilance team. This role is critical in ensuring the timely and accurate submission of ICSRs and aggregate reports to regulatory authorities in compliance with global pharmacovigilance regulations and guidelines. Functional Responsibilities: • Manage timely submission of global ICSRs to health authorities, license partners, and CROs. • Prepare local paper submissions to the US FDA, following client-specific processes. • Proficient in ICSR submissions including MedWatch, CIOMS I, E2B(R2), and E2B(R3) for approved and investigational drugs, biologics, and medical devices. • Support safety reporting for aggregate reports/periodic safety reports and related activities. • Perform and oversee aggregate report submissions to regulatory authorities (RAs), ethics committees (ECs), institutional review boards (IRBs), and investigators. • Track and archive aggregate report submissions and correspondence. • Support EudraVigilance registration and account maintenance, as well as registration to other regulatory portals for submissions. • Generate, review, and transmit reports to global health authorities (e.g., FDA, EMA, MHRA, Health Canada). • Stays updated on regulatory requirements through regulatory intelligence to ensure compliance with submission rules across global health authorities • Maintaining the submission requirements tracker with country-level safety reporting requirements. • Ensure timely report submissions to global partners in line with PVAs. • Participate in gateway-to-gateway ICSR submission testing with health authorities and partners. • Prepare ICSR submission packages per regulatory requirements. • Monitor global submission mailboxes to address high-priority queries from authorities and partners. • Manage daily submission worklists to meet deadlines across all destinations. • Monitor the safety database for failed transmissions and resolve them promptly. • Coordinate with case processors and medical reviewers for timely case corrections. • Investigate late submissions, identify root causes, and implement corrective and preventive actions. • Provide training and mentorship to new submission team members. • Maintain accurate and up-to-date reporting rules in the safety database. • Stay informed on global PV regulations and ensure compliance in all submission activities. • Review PV Agreements and Safety Management Plans for updates impacting reporting configuration. Other Details: • Maintain comprehensive documentation of submission activities for audit and inspection readiness. Education: University degree in Life Sciences; Master’s degree preferred. Skills and personal attributes: • Fluency in spoken and written English; Good Communication skills. • Ability to work in a team with ability to prioritize the assigned work. • Proficiency in MS Office suite (Word/Excel/ PowerPoint). Minimum Work Experience: Must have a minimum of 3- 4 years of submission experience and strong knowledge of regulatory guidelines/requirements

Summary In line with overall product strategy, the Medical Advisor is responsible for supporting the design, implementation and execution of Medical Affairs plans for assigned Therapy Area, providing scientific information, helping design & organise clinical studies, building educational dialogue with KOLs and regulatory stakeholders About The Role Key Responsibilities Support country medical affairs strategy in line with the global strategy, country insights and market conditions, and implementation of Medical Affairs activities within the designated therapy area(s). Coordinate scientific meeting, symposia, congresses, Continuous Medical Education (CME) and other medical / scientific exchange and engagement activities which could bring value to the therapy area; develop engagement plan(s) for country customer-facing activities and events, and ensure timely execution of the activities in an efficient and compliant way. Ensure enquiries are responded to in a quality, timely manner, and in accordance with applicable standards; establish response documents for frequently asked questions. Provide medical/scientific input into the development and execution of clinical trial or clinical research related activities, including initiation and oversight of clinical studies / clinical research within the therapeutic area. Support country strategy for Non Interventional Studies/Investigator Initiated Trial activities. Coordinate review and approval of medical materials and locally developed promotional materials; ensure medical materials provided from global or region for partner engagement and events are tailored to local needs, and reviewed/approved per local/P3 guidelines. Ensure medical insights are provided to cross-functional groups, including, but not restricted to: Pharmacovigilance, Regulatory Affairs, Market Access, QA, Commercial and Brand team and others. Responsible for risk identification and assessment, mitigation planning as well as implementation and monitoring of appropriate internal controls within the area of responsibilities Essential Requirements MBBS; MD Mandatory with min 1+ year industry experience Operations Management and Execution Project Management Collaborating across boundaries Clinical Trial Design, Data & Reporting Medical Science and Disease Area Knowledge Medical Education and Scientific Engagement Non-Interventional Studies (NIS) / Epidemiology Studies Medical Governance and Medical Safety Desirable Requirements: Cardiovascular Why 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 You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards 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. Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message. 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

Location Bengaluru, Karnataka, India Job ID R-226571 Date posted 03/07/2025 Job Title: Associate Director, Patient Safety Scientist Global Career Level: E Introduction to role: The Associate Director, Patient Safety Scientist role works collaboratively with the Global Safety Physician (GSP) and Senior Patient Safety Scientist to review safety data and related documents for potential safety issues. This role involves authoring and providing pharmacovigilance input to safety documents and regulatory reports. The Associate Director also leads meetings and presents safety data and analyses. Accountabilities: Leads and/or conducts proactive pharmacovigilance and risk management planning for designated products, including preparation of safety aspects of Global Risk Management Plans, in partnership with the GSP and others as appropriate. Represents Patient Safety on cross-functional project teams for marketed products and/or developmental compounds. Presents safety information at external meetings. Performs duties as a Safety Strategy and Management Team (SSaMT) leader. Presents issues to the Safety Information Review Committee (SIRC) and takes the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP, and other key stakeholders. Produces accurate and fit-for-purpose evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data. Collaborates with GSP and Clinical representatives to author the Reference Safety Information (RSI) for assigned marketed products and/or development products; coordinates meetings and tracks timelines to ensure completion. Proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, literature, and other information sources to establish the safety profile of drugs and manage the risk to patients. Authors/provides strategic input or oversight for periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines. Contributes to the Patient Safety component of contracts/agreements with third parties to ensure quality and integrity of agreement. Trains junior members of the team in Patient Safety tools and systems. Authors/provides strategic input to regulatory submissions for new products, formulations, or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts. Essential Skills/Experience: Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background, with proven competency in patient safety/clinical development Comprehensive understanding of applicable Patient Safety regulatory obligations Awareness of Patient Safety policies, processes, and procedures Awareness of medico-legal aspects of patient safety 9 to 11 years of Patient Safety experience Total of 12 to 14 years of experience Communication: Well-developed interpersonal skills Cultural sensitivity Ability to network with other functions globally Impact on Business Results: Quality and timeliness of work through surveillance and case handling activity Provision of timely information, meeting deadlines for compliance with regulatory reporting requirements for periodic reports, safety due diligence of products, and contributing to correct labeling through safety surveillance activities Maintenance of efficient and effective processes, with a focus on productivity Internal and External Contacts/Customers: Patient Safety personnel at all levels Regulatory Affairs and other AstraZeneca personnel Leadership Skills: Passion for Customers: Engages in collaboration with customers by directly interacting with them to ensure delivery of a complete solution. Thinks Strategically: Applies a broad perspective by using knowledge and experience to challenge and adapt current approaches/ways of doing things. Acts Decisively: Makes effective decisions under pressure in the absence of complete information and seeks support when needed. Drives Performance: Holds immediate team accountable to quality standards by clarifying the objectives and timelines for deliverables. Works Collaboratively: Integrates diverse views by seeking input and incorporating cross-functional views into decisions/proposals. Develops People and Organisation: Provides support and feedback to junior staff while continuing to develop him/herself. 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, we follow the science and pioneer new frontiers. Join our team dedicated to Oncology with an ambition to eliminate cancer as a cause of death. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Fusing cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we aim to deliver 6 new molecular entities by 2025. Our courage, curiosity, and collaboration drive us to make bold decisions driven by patient outcomes. Empowered to lead at every level, we are free to ask questions and take smart risks that write the next chapter for our pipeline and Oncology team. Pioneers of collaborative research, we have built an unrivalled scientific community both internally and externally. Working seamlessly and inclusively, together we expedite research in some of the hardest-to-treat cancers. Join us to build a rewarding and meaningful career as part of a team committed to improving the lives of millions with cancer. Ready to make a difference? Apply now! Date Posted 04-Jul-2025 Closing Date 08-Jul-2025 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Pharmacy,BSc. Nursing,Bachelor of Physiotheraphy Years of Experience: 1 to 2 year About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. What are we looking for? Looking for the candidate with Good Communication and written skills, Bachelor of Pharmacy,Bachelor of Physiotheraphy,BSc. Nursing Roles and Responsibilities: n this role you are required to solve routine problems, largely through precedent and referral to general guidelines,Your expected interactions are within your own team and direct supervisor. You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments Bachelor of Pharmacy,BSc. Nursing,Bachelor of Physiotheraphy

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Pharmacy/Bachelor of Physiotheraphy/BSc. Nursing Years of Experience: 0 to 1 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Adaptable and flexible Agility for quick learning Ability to work well in a team Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Bachelor of Pharmacy,Bachelor of Physiotheraphy,BSc. Nursing

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Pharmacy,BSc. Nursing,Bachelor of Physiotheraphy Years of Experience: 1 to 2 year About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. database as per client guidelines and applicable global regulatory requirements. What are we looking for? Looking for the candidate with Good Communication and written skills, Bachelor of Pharmacy,Bachelor of Physiotheraphy,BSc. Nursing Roles and Responsibilities: n this role you are required to solve routine problems, largely through precedent and referral to general guidelines, Your expected interactions are within your own team and direct supervisor.You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments Bachelor of Pharmacy,BSc. Nursing,Bachelor of Physiotheraphy

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. The Medical Information Admin Assistant provides comprehensive administrative support to the Medical Information (MI) Enquiry Handling teams and Senior Management in an accurate and efficient manner. Responsibilities General administrative duties as delegated by management. Answering the main telephone line of the Company in a professional manner and transferring calls as appropriate. On an ad-hoc basis providing reception cover which includes meeting, greeting, and signing in all visitors to the ProPharma office in a friendly, courteous, and professional manner. Supporting the filing clerks, including opening the daily mail received into the company, franking, and posting the mail, filing, archiving and checking stationery stocks. Effectively perform in at least three task areas. Quality Assurance Maintaining a good level of quality in all aspects of the job. Complying with the procedures documented in the Company Standard Operating Procedures (SOPs) and Working Instructions (WIs). General Having a solid working knowledge of, and complying with, the Standard Operating Procedures of ProPharma Working in a professional manner at all times, with clients, customers, team members and management. Complying with the Company’s Health and Safety Policies. Ensuring the Confidentiality Statement within the Contract of Employment is always adhered to in respect of the data and property of ProPharma, its clients and employees of the business. Ensuring that any confidential information or personal data related to ProPharma and its clients is managed in accordance with Data Privacy regulations as described in ProPharma SOPs. Other duties as assigned. Necessary Skills And Abilities Able to work within a team in a professional manner. Sound written and oral communication skills. Good accuracy and attention to detail skills. Solid level of productivity on all tasks. Sound organizational and prioritizing skills showing an effective workload management system. Able to understand and follow processes. Pleasant and professional telephone manner. Computer literacy (MS Office). We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us Your Role Generate or convert doctors for our product portfolio. Secondary sales – Ensuring to achieve secondary sales targets through prescription generation by each of his BE. Good at relationship with KOLs (Top Physicians, Endocrinologists & Cardiologists) Day to day sales reporting Effective query handling and customer queries. Ensuring 100% Implementation of Company’s strategies Pharmacovigilance (Adverse Event Reporting) – To collect adverse drugs reaction (ADR) incidences including lack of efficacy related to medicinal products up to the maximum possible level of completeness and forward to local Patient Safety team immediately within 24 hours of ADR awareness. The additional information can be submitted as soon as possible Who You Are Any graduate Freshers or minimum of 1-2 years of experience in any pharma company Should have strong product knowledge & communication skills What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of our diverse team!

The PV Scientist Manager is responsible for the following: Contributes to the planning, preparation, writing and review of non-medical portions of aggregate reports Works with affiliates and other internal Amgen partners regarding deliverables Review of AE/SAEs from clinical trials as needed Contributes under the direction of the Global PV Sr. Scientist or Lead to: Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents Review standard design of tables, figures, and listings for safety data from clinical studies Participate in development of safety-related data collection forms for clinical studies Attend study team meetings as requested or needed Conduct signal detection, evaluation, and management Perform data analysis to evaluate safety signals and write up analysis results in collaboration with GSO Prepare safety assessment reports and other safety documents and regulatory responses Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection Participates in Safety Governance per Amgen processes Prepare presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making body Assist GSOs and other Senior Scientists in the development of risk management strategy and activities Provides contents for risk management plans Update strategy and content for regional risk management plans Assist GSOs to oversee risk minimization activities including tracking of activities as needed Evaluate risk minimization activity Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO Support activities related to new drug applications and other regulatory filings Assist GSO/ or other Senior Scientist in developing a strategy for safety-related regulatory activities Provide safety contents for filings Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor Inspection Readiness: Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility The PV Scientist contributes to GPS in the following ways: Contribute to the development, improvement, and standardization of pharmacovigilance processes and methods Participates on teams for the implementation of new processes and methods within the Therapeutic Area Basic Qualifications and Experience: Master’s or Bachelor's degree with minimum 9+ years of experience in relevant fields.

We are looking for a highly motivated and detail-oriented individual to join our team as a Trainee Medical Reviewer in Bengaluru. The ideal candidate should have 0-1 years of experience. Roles and Responsibility Conduct thorough medical reviews of patient records and reports to ensure accuracy and compliance with regulatory requirements. Collaborate with cross-functional teams to identify and resolve issues related to medical review. Develop and maintain expertise in medical terminology, regulations, and guidelines. Provide high-quality support to the medical review team through data entry, documentation, and other administrative tasks. Participate in ongoing education and training to enhance knowledge and skills. Contribute to process improvements by identifying areas for enhancement and implementing changes. Job Strong understanding of medical terminology, regulations, and guidelines. Excellent analytical, communication, and problem-solving skills. Ability to work effectively in a team environment and build strong relationships with colleagues. Proficiency in Microsoft Office and other software applications. Strong attention to detail and ability to prioritize tasks. Ability to adapt to changing priorities and deadlines in a fast-paced environment. About Company Omega Healthcare Management Services Private Limited is a leading provider of healthcare management services, committed to delivering high-quality solutions to its clients. We offer a dynamic and supportive work environment, with opportunities for growth and development.

As a Therapy Business Manager you will be responsible for the development and performance of all sales strategies in assigned market. Further you will drive primary sales, secondary sales and ensuring brand presence in defined markets. You will supervise/manage the distributor network to achieve desired sales objectives thereby ensuring achievement of financial and ethical objectives of the division as per the business strategy. To achieve this you will have authority to develop your customer management plan, approve expiry products issue credit note for distributors under your control, recommending appointment and credit limits of distributors, develop, execute & plan your resource utilization and participate in Strategy Execution review meetings to ensure alignment. You have a very important role to play in Divisions success. Roles and Responsibilities in detail Territory Business Planning: Plan for the monthly and quarterly business. Plan demand generation and fulfillment Monitor actual Sales and mid-course corrections and inputs to reduce variance against expectations Prescription audit for Abbott brands and other competitors brands To create and update customer list having specified number of doctors /chemist (Trade) as per the therapy /product requirement and maintain the same in physical/electronic format. Business generation & development: Achieve monthly, quarterly, half-yearly, and yearly Sales targets by promoting companies products ethically to customers as per the business plan Having science base discussions with doctor and chemist for promotion of the product in the clinic and at the chemist place Organizing Camps (CME) as per the division strategy and customers need Execute the customer management plan to ensure that all the customers are covered as per the plan. Lead and execute strict adherence to Abbott Code of Business conduct Set examples on implementation of the code of business conduct, RCPA, Pharmacovigilance to ensure compliance Demonstrate and promote professional behavior in line with Abbott Values of Pioneering, Achieving, Caring, and Enduring Ensure a high level of customer service and manage any difficult customer situations. Division and business strategy will be shared with you on time to time base which you will have to execute to the fullest To attend and participate in Strategy meetings, briefing sessions, doctors meets, workshops, training programs, and any other programs undertaken by the company to equip you or activities for the performance of your job or promote the sales of products of the company or to improve company image. Meet minimum KPIs as follows: 100% coverage of Doctors. Customer Call average as per the customer management plan of the division /therapy. Market intelligence collection, retailer level inventory management calls as per the product profile and marketing strategy of the therapy /division. Experience/Training Required 2+ Years of experience. Candidate with prior/current experience in the same therapy. Candidates from MNC and top Indian Pharma companies will have added advantages. Fluent and confident in communication. LOCATION: India > Chennai : 147 Greams Road t

As a Therapy Business Manager you will be responsible for the development and performance of all sales strategies in assigned market. Further you will drive primary sales, secondary sales and ensuring brand presence in defined markets. You will supervise/manage the distributor network to achieve desired sales objectives thereby ensuring achievement of financial and ethical objectives of the division as per the business strategy. To achieve this you will have authority to develop your customer management plan, approve expiry products issue credit note for distributors under your control, recommending appointment and credit limits of distributors, develop, execute & plan your resource utilization and participate in Strategy Execution review meetings to ensure alignment. You have a very important role to play in Divisions success. Roles and Responsibilities in detail Territory Business Planning: Plan for the monthly and quarterly business. Plan demand generation and fulfillment Monitor actual Sales and mid-course corrections and inputs to reduce variance against expectations Prescription audit for Abbott brands and other competitors brands To create and update customer list having specified number of doctors /chemist (Trade) as per the therapy /product requirement and maintain the same in physical/electronic format. Business generation & development: Achieve monthly, quarterly, half-yearly, and yearly Sales targets by promoting companies products ethically to customers as per the business plan Having science base discussions with doctor and chemist for promotion of the product in the clinic and at the chemist place Organizing Camps (CME) as per the division strategy and customers need Execute the customer management plan to ensure that all the customers are covered as per the plan. Lead and execute strict adherence to Abbott Code of Business conduct Set examples on implementation of the code of business conduct, RCPA, Pharmacovigilance to ensure compliance Demonstrate and promote professional behavior in line with Abbott Values of Pioneering, Achieving, Caring, and Enduring Ensure a high level of customer service and manage any difficult customer situations. Division and business strategy will be shared with you on time to time base which you will have to execute to the fullest To attend and participate in Strategy meetings, briefing sessions, doctors meets, workshops, training programs, and any other programs undertaken by the company to equip you or activities for the performance of your job or promote the sales of products of the company or to improve company image. Meet minimum KPIs as follows: 100% coverage of Doctors. Customer Call average as per the customer management plan of the division /therapy. Market intelligence collection, retailer level inventory management calls as per the product profile and marketing strategy of the therapy /division. Experience/Training Required 2+ Years of experience. Candidate with prior/current experience in the same therapy. Candidates from MNC and top Indian Pharma companies will have added advantages. Fluent and confident in communication. LOCATION: India > Mumbai : BKC Building t

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 3 to 5 years Language - Ability: English(International) - Expert About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsDetail orientationAbility to establish strong client relationship Roles and Responsibilities: Data Review Report Programmers:Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred.Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support.Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery.Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred. Qualification BSc,Master of Pharmacy

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Specialist Qualifications: Bachelor of Pharmacy Years of Experience: 7 to 11 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. The role may require you to identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The role may also need expertise in managing clinical data management projects. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skills Roles and Responsibilities: Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred. o Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. o Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders. o Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery. o Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred. o Good analytical and communication skills. Qualification Bachelor of Pharmacy