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2.0 - 6.0 years
6 - 7 Lacs
Chennai, Thiruvananthapuram
Work from Office
PV Reporting Associate We are currently seeking a Pharmacovigilance Associate to join our diverse and dynamic team. As a Pharmacovigilance Associate at ICON, you will play a vital role in monitoring and ensuring the safety of pharmaceutical products by collecting, analyzing, and reporting adverse event information. Your attention to detail and understanding of regulatory requirements will be essential in supporting the organization s commitment to patient safety and compliance. What You Will Be Doing: Collecting and reviewing adverse event reports to ensure accurate and timely reporting in accordance with regulatory guidelines. Conducting signal detection and risk assessment activities to identify potential safety issues. Collaborating with cross-functional teams to support safety-related inquiries and investigations. Maintaining up-to-date knowledge of pharmacovigilance regulations and industry best practices. Assisting in the preparation of safety reports and regulatory submissions. Your Profile: Bachelors degree in life sciences, pharmacy, or a related field; advanced degree preferred. Experience in pharmacovigilance, drug safety, or a related area, preferably within a clinical or pharmaceutical environment. Strong analytical skills with attention to detail in data collection and reporting. Excellent communication and interpersonal skills, enabling effective collaboration with team members and stakeholders. A commitment to maintaining high standards of quality and compliance in all pharmacovigilance activities. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON EmployeePlease click here to apply
Posted 1 week ago
4.0 - 6.0 years
6 - 10 Lacs
Ahmedabad
Work from Office
Account Manager - Madhya Pradesh, Pharma, CRO & Clinical Research Labs Location: Ahmedabad, GJ, IN, 382110 Company: Actylis Actylis is a leading manufacturer and supplier of critical raw materials and performance ingredients serving the Life Sciences, Specialty Chemicals, and Agriscience industries. We offer standard and custom ingredients through our rapidly growing portfolio of GMP and non-GMP facilities worldwide, and further choice through our strong sourcing hub network. This unique hybrid option blending manufacturing and global sourcing, combined with more than 75 years of sourcing and distribution experience makes Actylis the Partner of Choice. Position Summary The Business Development Manager (BDM) is responsible for steering, planning, supporting, and executing acquisition of new customers and business in Pharmaceutical, Contract Research Organizations and Clinical Research Labs customer segment of Lab Chemicals business in alignment with overarching sales and corporate objectives. The position will be required to be customer facing , responsible for generating new customer leads through regular visits and follow-up to meet the sales objectives, convert leads / opportunity to confirmed orders, and sustain relationships with customers by establishing customer connect in unchartered markets and territories, and working closely with Account Managers and Field Sales personnel to execute on business growth opportunities throughout the assigned region. Responsibilities will include: Develop business development and sales growth plans of company s lab chemical products per assigned targets in large and mid-scale Pharmaceutical, CRO and Clinical Research Labs segments where such products are used for research, application, or other business purposes. Map the assigned markets, territories, and geographical regions to identify key potential customers and conduct preliminary assessment to assess realistic sales opportunities. Analyze and respond to RFP s/RFI s and quote requests in conjunction with sales team. Collaborate with Lab Chemicals Sales leadership and Sales Enablement teams to respond to government tenders, contracts, and RFPs. Study government s investment plans regarding Pharmaceutical, CRO and Clinical Research Labs segment and develop strategy to target market share using direct and indirect channels. Update customer data from time to time in CRM, submit activity and results reports, such as daily call reports, weekly work plans, monthly and annual account analysis. Collate market feedback on competitors activities such as product offerings, prices, new products, delivery schedules and provide inputs to sales leadership team for review of company s strategy and approach. Meet existing and potential clients and build positive relationships and pipeline of opportunities. Collaborate with sales team to develop targeted integrated delivery networks and business development opportunities. Identify market trends, assesses market potential, and develop strategies to grow Pharmaceutical, CRO and Clinical Research Lab segment s market share in the Lab Chemical space. Make presentations and implement development projects to customers, set in place the required project plans, execute the plan and close new business. Provide timely customer support and define and interface with internal resources, when necessary. Work with marketing, sales and product development to develop strategies that ensures Pharmaceutical, CRO and Clinical Research Lab segment s position as a multi products / solutions provider for customers existing products and new product introductions. Work with global support teams throughout the development process and render technical support to customers wherever needed. Continuously strive to create right balance, and co-working culture within the team to ensure smooth working and timely delivery of projects. Be prompt in handling queries, complaints and take relevant actions to keep the momentum going and achieve final objective. Assist to provide ad hoc reports (usage, price lists) Required Experience & Knowledge Education Graduate / Postgraduate in Science with specialization in Chemistry; MBA is an added advantage. Experience Minimum 4-6 years of work experience in handling specialty chemicals portfolio. Prior experience in life science / pharma industry is recommended. Functional / Technical Competencies & Skillsets Ability to develop business growth plans supported with factual data. Negotiation, communication, and presentation skills. Knowledge in working with CRM. Business development mindset through identifying target set of customers and executing agreed plans. Ability to manage, identify and establish the channel network. Teamwork and collaboration. Physical Demand Supervisory Responsibilities None Work Environment Actylis is an Equal Opportunity Employer. Actylis does not discriminate on the basis of race, religion, color, sex, gender identity or expression, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided based on qualifications, merit, and business need.
Posted 1 week ago
4.0 - 6.0 years
9 - 13 Lacs
Bengaluru
Work from Office
Job Description Summary Compliance and Validation Hands-on experience in the role of Compliance and Validation Well-versed with GxP, GDPR, FDA, Part 11, and standard regulations Knowledge of 21 CFR part 11, GxP regulations, GAMP 5 guidelines System validation in alignment with GxP and regulatory requirements Good knowledge of assessing Traceability gaps, improper verification of requirements, improper attached evidences, and raised observations for each deviation Hands-on experience in reviewing validation artifacts, and quality reviews System Life Cycle and Methodologies Well-versed with System Life Cycle Hands-on experience with Validation approach, Agile methodology, AIML concepts Testing/Validation Experience Exposure in reviewing Test Plans, Test Summary Reports Development of System Validation Lifecycle documents Risk Analysis, Validation Plan, Validation Summary Report Preparation and Review of validation deliverables (Validation plan, Functional Risk Assessment, Requirement Traceability Matrix, Qualification Summary Report) Good knowledge about the defect life cycle Tools and Technologies - Hands-on experience with tools like HP ALM, Jira, TrackWise, Veeva, QMS systems Quality Management - Knowledge of Quality Management System (QMS) Domain Knowledge - Healthcare, CRO, Life Sciences domain knowledge Good to Have Skills : SaaS Validation and Process -Familiarity with SaaS validation and process System Validation Analysis and development of System Validation Lifecycle documents Risk Analysis of system and requirements. Compliance and Audits - IT and CSV compliance and audit of third-party vendors, Participation in internal audits and/or regulatory audits to represent CSV and IT compliance. Vendor Management - Vendor evaluation and qualification Testing/Validation Process - Knowledge about Testing/Validation process, automation Software Development Life Cycle (SDLC) - Good knowledge about the SDLC process Data Management and Risk-Based Approach - Good knowledge on data management, risk-based approach Documentation - Experience in authoring and improving SOPs, work instructions, and templates . 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
Posted 1 week ago
2.0 - 6.0 years
6 - 7 Lacs
Chennai, Thiruvananthapuram
Work from Office
PV Reporting Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Pharmacovigilance Associate to join our diverse and dynamic team. As a Pharmacovigilance Associate at ICON, you will play a vital role in monitoring and ensuring the safety of pharmaceutical products by collecting, analyzing, and reporting adverse event information. Your attention to detail and understanding of regulatory requirements will be essential in supporting the organization s commitment to patient safety and compliance. What You Will Be Doing: Collecting and reviewing adverse event reports to ensure accurate and timely reporting in accordance with regulatory guidelines. Conducting signal detection and risk assessment activities to identify potential safety issues. Collaborating with cross-functional teams to support safety-related inquiries and investigations. Maintaining up-to-date knowledge of pharmacovigilance regulations and industry best practices. Assisting in the preparation of safety reports and regulatory submissions. Your Profile: Bachelors degree in life sciences, pharmacy, or a related field; advanced degree preferred. Experience in pharmacovigilance, drug safety, or a related area, preferably within a clinical or pharmaceutical environment. Strong analytical skills with attention to detail in data collection and reporting. Excellent communication and interpersonal skills, enabling effective collaboration with team members and stakeholders. A commitment to maintaining high standards of quality and compliance in all pharmacovigilance activities. What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles.
Posted 1 week ago
4.0 - 13.0 years
25 - 30 Lacs
Bengaluru
Work from Office
Jul 16, 2025 Location: Bengaluru Designation: Manager Entity: Deloitte Touche Tohmatsu India LLP Your potential, unleashed. India s impact on the global economy has increased at an exponential rate and Deloitte presents an opportunity to unleash and realise your potential amongst cutting edge leaders, and organisations shaping the future of the region, and indeed, the world beyond. At Deloitte, your whole self to work, every day. Combine that with our drive to propel with purpose and you have the perfect playground to collaborate, innovate, grow, and make an impact that matters. The team Deloitte helps organizations prevent cyberattacks and protect valuable assets. We believe in being secure, vigilant, and resilient not only by looking at how to prevent and respond to attacks, but at how to manage cyber risk in a way that allows you to unleash new opportunities. Embed cyber risk at the start of strategy development for more effective management of information and technology risks Your work profile As Manager in our Cyber Team you ll build and nurture positive working relationships with teams and clients with the intention to exceed client expectations: - Responsibilities will include but are not limited to: Managing and supporting portfolio of OT/ICS security engagements with our clients, responsible for the day to day running of the engagements, including meeting quality, time, and budget targets Collaborating with prospective clients to agree, scope and plan the delivery phase of engagements. Contributing to developing the market for OT/ICS security services across all sectors, identifying sales opportunities and working with senior practice and market leaders in the creation of proposals and marketing material Developing team members by sharing knowledge, mentoring, and coaching them and leading by example Helping seniors in creating thought leadership and market materials for selling and promoting Deloitte Cyber and OT/ICS security offerings Skills needed: Be professional, quickly establishing personal credibility and demonstrating expertise. Be a good communicator with the ability to contribute assuredly to technical security discussions with peers and management. Be a team player who is not only looking to enhance their own career but recognizes the value of teamwork, facilitating and encouraging collaboration amongst team members, capable of motivating teams to maximize performance. Be able to analyses complex problems and deliver insightful, practical, and sustainable solutions. Structure and manage projects which meet client expectations and mitigate any risks or issues. Professional experience operating as a skilled OT/ICS resource in a management capacity in the design, implementation, maintenance, or support of security solutions within OT/ICS environments. A detailed understanding of OT/ICS Security standards and framework, including such families as ISA/IEC 62443, NIST 800-82. Experience in the application of security-related operational processes in the OT/ICS environments risk management practices within OT/ICS environments technologies (assets/systems, communication protocols, technical architectures) utilized by OT/ICS systems and networks. Knowledge of the technical security concepts/solutions utilized within IOT/ICS systems and networks. Knowledge of OT/ICS security event monitoring in a security operation setting Practical application of OT/ICS risk mitigation Key sector experience in one or more of the following Government & Public sector / Energy & Utilities / Retail and Consumer products / Life sciences / Telecoms, Media, and Technology / Transport Location and way of working Base location: Mumbai Professional is required to work from office Your role as a Manager We expect our people to embrace and live our purpose by challenging themselves to identify issues that are most important for our clients, our people, and for society. In addition to living our purpose, Senior Executive across our organization must strive to be: Inspiring - Leading with integrity to build inclusion and motivation Committed to creating purpose - Creating a sense of vision and purpose Agile - Achieving high-quality results through collaboration and Team unity Skilled at building diverse capability - Developing diverse capabilities for the future Persuasive / Influencing - Persuading and influencing stakeholders Collaborating - Partnering to build new solutions Delivering value - Showing commercial acumen Committed to expanding business - Leveraging new business opportunities Analytical Acumen - Leveraging data to recommend impactful approach and solutions through the power of analysis and visualization Effective communication Must be well abled to have well-structured and well-articulated conversations to achieve win-win possibilities Engagement Management / Delivery Excellence - Effectively managing engagement(s) to ensure timely and proactive execution as well as course correction for the success of engagement(s) Managing change - Responding to changing environment with resilience Managing Quality & Risk - Delivering high quality results and mitigating risks with utmost integrity and precision Strategic Thinking & Problem Solving - Applying strategic mindset to solve business issues and complex problems Tech Savvy - Leveraging ethical technology practices to deliver high impact for clients and for Deloitte Empathetic leadership and inclusivity - creating a safe and thriving environment where everyones valued for who they are, use empathy to understand others to adapt our behaviours and attitudes to become more inclusive.
Posted 1 week ago
5.0 - 10.0 years
6 - 11 Lacs
Kolkata
Work from Office
Job Overview Apply knowledge and expertise including complex decision making activities to review, assess and process Safety data and information across service lines. Recognized as specialist in one or more areas. Provide oversight on small to medium service operational projects and act as mentor to junior members of staff. Essential Functions Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements. To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information determining initial/update status of incoming events database entry coding AE and Products, writing narratives, Literature related activities, Quality review, assisting with reconciliation, case closure related activities, coordinating translations, as per internal/ project timelines. Creating, maintaining and tracking cases as applicable to the project plan. Perform activities related to adjudication as applicable Assess Safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to meet requirement as per project. Liaise with relevant stakeholders to facilitate expedited reporting. Liaise with manager for regulatory tracking requirements and electronic reporting. Contribute knowledge and expertise to or lead assigned deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate. Ensure to meet quality, productivity and delivery standards per project requirements. Ensure compliance to all project related processes and activities. Build a positive, collaborative team environment with Safety team members, lead by example, provide training and mentoring for less experienced team members and operations staff, assist Operations Manager as a backup when needed. Provide and impart technical and process information to Safety Management and members of operational team on project specific issues. Provide oversight role and have a good understanding of operational team on status, metrics, productivity and initiatives. Maintain a thorough understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects set up and maintain project files, standard templates, electronic forms, databases and workflow as per project requirement. Establish and maintain effective team and project service operations communications i.e. provide regular feedback to operations team manager and other relevant stakeholders on project metrics, out of scope work challenges/issues and successes effective feedback on project performance to junior members of team. Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring completeness of individual training plan and maintain up to date training transcripts. Participate or Lead trainings across Safety process service offerings participate in working groups as applicable in implementation of new initiatives, identification and implementation of process efficiencies. To demonstrate problem solving capabilities. Liaise with different functional team members, e.g. project management, clinical, data management health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues. Attend project team meetings and provide regular feedback/ inputs to Operations team manager on operational project metrics, out of scope work challenges/issues and successes. To liaise with client in relation to details on day to day activities as needed. Contribute to achievement of departmental goals Perform other duties as assigned 100% compliance towards all people practices and processes In addition to the above mentioned responsibilities, depending on the project requirement, the team member may perform medical review of non-serious adverse events (AEs) and non-serious adverse drug reactions (ADRs) which includes reviewal of AE coding, past medical history, concomitant medications, expectedness/ listedness, causality assessment and other medical information and ensure completeness and accuracy of data according to applicable regulations and guidelines, SOPs, project-specific guidelines, and medical evaluation guidelines and communicate with the team leads for any correction required in the case and maintain appropriate documentation for all communications. Qualifications Bachelors Degree Scientific or healthcare discipline or allied life sciences Req Bachelors degree in life sciences or related field and up to 5 years of relevant experience, inclusive of up to 3 years of Pharmacovigilance experience. Req or equivalent combination of education, training and experience. Pref Excellent knowledge of medical terminology. Intermediate In depth knowledge and understanding of applicable Safety Database and any other internal/Client applications. Advanced In depth knowledge and understanding of applicable global, regional, local clinical research regulatory requirements. Advanced Excellent organizational skills, time management skills, attention to detail and accuracy. Advanced maintain high quality standards. Advanced Excellent working knowledge of Microsoft Office and web-based applications. Intermediate To demonstrate effective project management and leadership skills. Intermediate Effective mentoring and coaching skills. Advanced Excellent verbal/written communication skills. Advanced Self-motivated, flexible, receptive to changing process demands. Advanced willingness and aptitude to learn new skills across Safety service lines. Advanced Proven ability to work independently and autonomously with policies and practices. Advanced Proven ability to multi-task, meet strict deadlines, manage competing priorities. Advanced Ability to identify, prioritize tasks and delegate to team members. Advanced Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients. Advanced Ability to work as a Team Player, contribute and work towards achieving Team goals. Advanced Demonstrate Sound judgment and decision making skills. Advanced Ability to work effectively on multiple projects simultaneously, organize own workload and effectively manage teams priorities. Intermediate Ensure quality of deliverables according to the agreed terms. Advanced Demonstration of IQVIA core values while doing daily tasks. Advanced Skill to plan work load based on available capacity and ability to change prioritization based on workload fluctuations. Intermediate Skill to negotiate and work on finding a central ground that is satisfactory to all concerned stake holders. Intermediate Support audit preparedness Advanced Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Intermediate Regular sitting for extended periods of time. Intermediate May require occasional travel. Intermediate Flexibility to operate in shifts. Advanced 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 Let s stay connected. 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Posted 1 week ago
3.0 - 5.0 years
11 - 15 Lacs
Kolkata, Mumbai, New Delhi
Work from Office
About the role: The Senior Regulatory Start Up Associate is primarily responsible for planning, preparation, review of country and site level ethics and regulatory authority applications and submissions during project start-up, in compliance with ICH-GCP and local regulatory requirements, to ensure timely clinical trial approval. Minimum Qualifications & Experience: Graduate in a clinical, pharmacy or life sciences related field. At least 3-5 years of related experience in either a CRO, pharmaceutical or clinical/hospital environment. Responsibilities: Serve as the primary point of contact for the Regulatory Start-Up Manager (RSM) and/or Project Manager (PM) during start-up on allocated projects. Provide expertise and guidance to RSM and/or PM on country and local regulations and practices, keeping abreast of developments and changes in regulations, guidelines and practices surrounding clinical trial approvals in relevant countries. Work within the scope of the Regulatory Start-Up plan or other applicable project plan, relevant SOPs, and ICH-GCP. Provide country and site level information on submission deadlines and timeline metrics for local Regulatory Authority, Ethics Committees, Investigational Review Boards and other local bodies as appropriate. Works within forecasted submission/approval timelines and ensures they are complied with, updating appropriate systems accurately and in a timely manner, including planned and actual dates of submissions/approvals. May serve as a point of contact with investigative sites for Regulatory Authority, Ethics Committees/Review Boards and other local authority related activities. Prepare and submits Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required. Ensure submission packages are accurate and complete per local requirements. Review and follow-up on comments/questions raised by reviewing bodies and advise/contribute to response. Submit response with Client approval within timeframe. Follow submission, application to approval. May serve as a point of contact for Regulatory Authorities, Ethics Committees/Review Boards and other local authorities. Prepare and submit ongoing amendments, notifications, safety reports and study related materials required by Regulatory Authorities, Ethics Committees/Review Boards and other local authorities as per local requirements. Escalate any issue to the RSM and/or PM and provides rationale for submission/approval delays, and contingency plan to mitigate impact. Perform country and site Informed Consent Form (ICF) customization in line with local requirements. Initiate translation of submission documents as applicable and review translated documents before submission. Review and approve proposed packaging and labelling for clinical trial material. Prepare and submits import/export license applications and management of licenses and custom clearance thereafter if required. Register project onto an official clinical trial registry as agreed to with Client and update status as required. Submit regulatory and ethics documents and relevant study correspondence to the trial master file and ensures accuracy and completeness of these documents. Serve as an independent essential document reviewer and performs 2nd review of Activation Forms for IP release if required. Where applicable, may act as a Country Lead for projects with no RSM. At least 3-5 years Regulatory Start-up experiences in clinical industry. Responsible for development of master and country ICFs, study specific forms and other documents required for Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required. Participate in company start-up initiatives, contributing to development and maintenance of regulatory start-up processes, tools and SOPs. Identify areas of inefficiency in process and make recommendations for improvements. Assist with RSA training in the development and delivery of training in conjunction with Learning and Development Manager and serve as a mentor to junior RSAs. Serve as the local subject matter expert on specialized aspects of regulatory and start -up activities. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Minimum Qualifications & Experience: Graduate in a clinical, pharmacy or life sciences related field. At least 3-5 years of related experience in either a CRO, pharmaceutical or clinical/hospital environment. Responsibilities: Serve as the primary point of contact for the Regulatory Start-Up Manager (RSM) and/or Project Manager (PM) during start-up on allocated projects. Provide expertise and guidance to RSM and/or PM on country and local regulations and practices, keeping abreast of developments and changes in regulations, guidelines and practices surrounding clinical trial approvals in relevant countries. Work within the scope of the Regulatory Start-Up plan or other applicable project plan, relevant SOPs, and ICH-GCP. Provide country and site level information on submission deadlines and timeline metrics for local Regulatory Authority, Ethics Committees, Investigational Review Boards and other local bodies as appropriate. Works within forecasted submission/approval timelines and ensures they are complied with, updating appropriate systems accurately and in a timely manner, including planned and actual dates of submissions/approvals. May serve as a point of contact with investigative sites for Regulatory Authority, Ethics Committees/Review Boards and other local authority related activities. Prepare and submits Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required. Ensure submission packages are accurate and complete per local requirements. Review and follow-up on comments/questions raised by reviewing bodies and advise/contribute to response. Submit response with Client approval within timeframe. Follow submission, application to approval. May serve as a point of contact for Regulatory Authorities, Ethics Committees/Review Boards and other local authorities. Prepare and submit ongoing amendments, notifications, safety reports and study related materials required by Regulatory Authorities, Ethics Committees/Review Boards and other local authorities as per local requirements. Escalate any issue to the RSM and/or PM and provides rationale for submission/approval delays, and contingency plan to mitigate impact. Perform country and site Informed Consent Form (ICF) customisation in line with local requirements. Initiate translation of submission documents as applicable and review translated documents before submission. Review and approve proposed packaging and labelling for clinical trial material. Prepare and submits import/export license applications and management of licenses and custom clearance thereafter if required. Register project onto an official clinical trial registry as agreed to with Client and update status as required. Submit regulatory and ethics documents and relevant study correspondence to the trial master file and ensures accuracy and completeness of these documents. Serve as an independent essential document reviewer and performs 2nd review of Activation Forms for IP release if required. Where applicable, may act as a Country Lead for projects with no RSM. At least 3-5 years Regulatory Start-up experiences in clinical industry. Responsible for development of master and country ICFs, study specific forms and other documents required for Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required. Participate in company start-up initiatives, contributing to development and maintenance of regulatory start-up processes, tools and SOPs. Identify areas of inefficiency in process and make recommendations for improvements. Assist with RSA training in the development and delivery of training in conjunction with Learning and Development Manager and serve as a mentor to junior RSAs. Serve as the local subject matter expert on specialised aspects of regulatory and start -up activities. About the role: The Senior Regulatory Start Up Associate is primarily responsible for planning, preparation, review of country and site level ethics and regulatory authority applications and submissions during project start-up, in compliance with ICH-GCP and local regulatory requirements, to ensure timely clinical trial approval. Minimum Qualifications & Experience: Graduate in a clinical, pharmacy or life sciences related field. At least 3-5 years of related experience in either a CRO, pharmaceutical or clinical/hospital environment. Responsibilities: Serve as the primary point of contact for the Regulatory Start-Up Manager (RSM) and/or Project Manager (PM) during start-up on allocated projects. Provide expertise and guidance to RSM and/or PM on country and local regulations and practices, keeping abreast of developments and changes in regulations, guidelines and practices surrounding clinical trial approvals in relevant countries. Work within the scope of the Regulatory Start-Up plan or other applicable project plan, relevant SOPs, and ICH-GCP. Provide country and site level information on submission deadlines and timeline metrics for local Regulatory Authority, Ethics Committees, Investigational Review Boards and other local bodies as appropriate. Works within forecasted submission/approval timelines and ensures they are complied with, updating appropriate systems accurately and in a timely manner, including planned and actual dates of submissions/approvals. May serve as a point of contact with investigative sites for Regulatory Authority, Ethics Committees/Review Boards and other local authority related activities. Prepare and submits Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required. Ensure submission packages are accurate and complete per local requirements. Review and follow-up on comments/questions raised by reviewing bodies and advise/contribute to response. Submit response with Client approval within timeframe. Follow submission, application to approval. May serve as a point of contact for Regulatory Authorities, Ethics Committees/Review Boards and other local authorities. Prepare and submit ongoing amendments, notifications, safety reports and study related materials required by Regulatory Authorities, Ethics Committees/Review Boards and other local authorities as per local requirements. Escalate any issue to the RSM and/or PM and provides rationale for submission/approval delays, and contingency plan to mitigate impact. Perform country and site Informed Consent Form (ICF) customization in line with local requirements. Initiate translation of submission documents as applicable and review translated documents before submission. Review and approve proposed packaging and labelling for clinical trial material. Prepare and submits import/export license applications and management of licenses and custom clearance thereafter if required. Register project onto an official clinical trial registry as agreed to with Client and update status as required. Submit regulatory and ethics documents and relevant study correspondence to the trial master file and ensures accuracy and completeness of these documents. Serve as an independent essential document reviewer and performs 2nd review of Activation Forms for IP release if required. Where applicable, may act as a Country Lead for projects with no RSM. At least 3-5 years Regulatory Start-up experiences in clinical industry. Responsible for development of master and country ICFs, study specific forms and other documents required for Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required. Participate in company start-up initiatives, contributing to development and maintenance of regulatory start-up processes, tools and SOPs. Identify areas of inefficiency in process and make recommendations for improvements. Assist with RSA training in the development and delivery of training in conjunction with Learning and Development Manager and serve as a mentor to junior RSAs. Serve as the local subject matter expert on specialized aspects of regulatory and start -up activities. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Minimum Qualifications & Experience: Graduate in a clinical, pharmacy or life sciences related field. At least 3-5 years of related experience in either a CRO, pharmaceutical or clinical/hospital environment. Responsibilities: Serve as the primary point of contact for the Regulatory Start-Up Manager (RSM) and/or Project Manager (PM) during start-up on allocated projects. Provide expertise and guidance to RSM and/or PM on country and local regulations and practices, keeping abreast of developments and changes in regulations, guidelines and practices surrounding clinical trial approvals in relevant countries. Work within the scope of the Regulatory Start-Up plan or other applicable project plan, relevant SOPs, and ICH-GCP. Provide country and site level information on submission deadlines and timeline metrics for local Regulatory Authority, Ethics Committees, Investigational Review Boards and other local bodies as appropriate. Works within forecasted submission/approval timelines and ensures they are complied with, updating appropriate systems accurately and in a timely manner, including planned and actual dates of submissions/approvals. May serve as a point of contact with investigative sites for Regulatory Authority, Ethics Committees/Review Boards and other local authority related activities. Prepare and submits Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required. Ensure submission packages are accurate and complete per local requirements. Review and follow-up on comments/questions raised by reviewing bodies and advise/contribute to response. Submit response with Client approval within timeframe. Follow submission, application to approval. May serve as a point of contact for Regulatory Authorities, Ethics Committees/Review Boards and other local authorities. Prepare and submit ongoing amendments, notifications, safety reports and study related materials required by Regulatory Authorities, Ethics Committees/Review Boards and other local authorities as per local requirements. Escalate any issue to the RSM and/or PM and provides rationale for submission/approval delays, and contingency plan to mitigate impact. Perform country and site Informed Consent Form (ICF) customisation in line with local requirements. Initiate translation of submission documents as applicable and review translated documents before submission. Review and approve proposed packaging and labelling for clinical trial material. Prepare and submits import/export license applications and management of licenses and custom clearance thereafter if required. Register project onto an official clinical trial registry as agreed to with Client and update status as required. Submit regulatory and ethics documents and relevant study correspondence to the trial master file and ensures accuracy and completeness of these documents. Serve as an independent essential document reviewer and performs 2nd review of Activation Forms for IP release if required. Where applicable, may act as a Country Lead for projects with no RSM. At least 3-5 years Regulatory Start-up experiences in clinical industry. Responsible for development of master and country ICFs, study specific forms and other documents required for Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required. Participate in company start-up initiatives, contributing to development and maintenance of regulatory start-up processes, tools and SOPs. Identify areas of inefficiency in process and make recommendations for improvements. Assist with RSA training in the development and delivery of training in conjunction with Learning and Development Manager and serve as a mentor to junior RSAs. Serve as the local subject matter expert on specialised aspects of regulatory and start -up activities.
Posted 1 week ago
2.0 - 7.0 years
4 - 9 Lacs
Bengaluru
Work from Office
Job Overview Under general supervision, Prepares and/or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and/or external clients. Provides regulatory support for assigned projects. Essential Functions Acts as a Regulatory Team Member on small, straightforward regulatory projects and/or gets involved in a small single service project, under the guidance of senior staff; Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate; Experienced in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable; Prepares and/or reviews regulatory documentation in area of expertise, as appropriate; Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters; Understands the Scope of Work, deliverables for any given project; May prepare slides and background material for small, straightforward business development meetings under senior guidance and presents in client meetings by phone or in person; May prepare and deliver trainings, as appropriate; Performs other tasks or assignments, as delegated by Regulatory management; Responsible for making minor changes in systems and processes to solve problems where problems faced are not typically difficult or complex; Qualifications Bachelors Degree Degree in Lifescience or related discipline Req Or Masters Degree Degree in Lifescience or related discipline Req At least 2 years relevant experience Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate; Good, solid interpersonal communication (oral and written) and organisation skills; 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; Demonstrates self-motivation and enthusiasm; 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; 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; Applicable certifications and licenses as required by country, state, and/or other regulatory bodies . 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
Posted 1 week ago
3.0 - 6.0 years
14 - 17 Lacs
Ahmedabad
Work from Office
Apexon is a digital-first technology services firm specializing in accelerating business transformation and delivering human-centric digital experiences. We have been meeting customers wherever they are in the digital lifecycle and helping them outperform their competition through speed and innovation.Apexon brings together distinct core competencies in AI, analytics, app development, cloud, commerce, CX, data, DevOps, IoT, mobile, quality engineering and UX, and our deep expertise in BFSI, healthcare, and life sciences to help businesses capitalize on the unlimited opportunities digital offers. Our reputation is built on a comprehensive suite of engineering services, a dedication to solving clients toughest technology problems, and a commitment to continuous improvement. Backed by Goldman Sachs Asset Management and Everstone Capital, Apexon now has a global presence of 15 offices (and 10 delivery centers) across four continents. We enable #HumanFirstDigital Gen AI Consultant: Key Responsibilities: Design and implement GenAI-powered content summarization workflows using AWS services. Utilize Amazon Bedrock, SageMaker, or custom LLMs on EC2/EKS for building and deploying summarization models. Build and manage embedding pipelines using models like Amazon Titan Embeddings, OpenAI, or Hugging Face models. Integrate and optimize vector databases (e.g., Pinecone, Amazon OpenSearch, Weaviate, FAISS, or Milvus) for efficient semantic retrieval. Develop APIs and interfaces to access summarization outputs in real time. Ensure system scalability, performance, and security following AWS best practices. Collaborate with business and product stakeholders to understand use cases and refine output formats. Stay updated with the latest in GenAI, prompt engineering, and retrieval-augmented generation (RAG) techniques. Required Skills: 3 6+ years of experience in AI/ML, NLP, or data science. Proven experience with AWS AI/ML services: Amazon Bedrock, SageMaker, Lambda, Step Functions, S3, API Gateway, IAM, etc. Hands-on experience with LLMs (OpenAI, Anthropic, Cohere, etc.) and content summarization techniques. Proficiency in Python, especially for AI workflows and AWS SDK (boto3). Deep understanding of vector databases and semantic search. Experience with RAG (Retrieval-Augmented Generation) architectures. Familiarity with prompt engineering and LLM tuning strategies. Strong problem-solving, communication, and stakeholder management skills. Our Commitment to Diversity & Inclusion: Our Perks and Benefits: Our benefits and rewards program has been thoughtfully designed to recognize your skills and contributions, elevate your learning/upskilling experience and provide care and support for you and your loved ones. As an Apexon Associate, you get continuous skill-based development, opportunities for career advancement, and access to comprehensive health and well-being benefits and assistance. We also offer: o Group Health Insurance covering family of 4 o Term Insurance and Accident Insurance o Paid Holidays & Earned Leaves o Paid Parental LeaveoLearning & Career Development o Employee Wellness Job Location : Ahmedabad, India
Posted 1 week ago
0.0 - 4.0 years
2 - 6 Lacs
Hyderabad
Work from Office
Aragen is looking for Junior Research Associate to join our dynamic team and embark on a rewarding career journey. Research Support : JRFs work under the guidance of senior researchers or principal investigators on research projects. They assist in conducting experiments, data collection, literature reviews, and data analysis. Data Collection and Analysis : Collecting and recording data from experiments or research studies and using appropriate software or statistical tools for data analysis. Literature Review : Conducting comprehensive literature reviews to understand the current state of research in the field and to inform the research design and methodology. Experimental Work : Depending on the field, JRFs may perform laboratory experiments, fieldwork, surveys, or other research activities specific to their project. Documentation : Keeping detailed records of research procedures, findings, and outcomes. This documentation is critical for the research process and for publishing research results. Research Proposal Writing : Assisting in the preparation of research proposals and grant applications to secure funding for research projects.
Posted 1 week ago
1.0 - 5.0 years
3 - 7 Lacs
Hyderabad
Work from Office
Our Responsibility Careers Senior Research Associate Hyderabad, India DEPARTMENT Chemistry Solutions Office Location: Mallapur Hyderabad Years of experience: Salary Range: INR to (Annual) Scope This role is responsible for executing chemicals reactions to synthesize required quantities of molecules / compounds as per client specifications using efficient route and techniques. Responsibilities Set-up and execute reactions for synthesis of target molecules/ compounds: Understand the project requirements as specified by the client, the synthetic route Understand and discuss the MSDS (Material Safety Data Sheet) with team members Identify and mitigate any potential safety risk with the help of supervisor Plan and execute reactions with proper reagents and equipment (glassware, stirrers, vacuum pumps etc.) maintaining specified conditions (temperature, pressure etc.), with optimum usage and minimum wastage Ensure parallel execution of multiple reactions Monitor the reaction by observing progress by using analytical techniques Identify and execute appropriate workup and purification technique to produce an intermediary / final compound of desired quality Analyze analytical data, evaluate and interpret results from the synthesis and report Meet productivity benchmarks on number of reactions / number of steps / number of compounds / quality / compounds purity / project timelines Ensure safety at work through enforcement of good laboratory practices: Follow safety and quality systems in the labs Maintenance and usage of equipment/apparatus/instruments as per SOPs and general housekeeping norms Maintain records, data integrity and IP confidentiality: Document reactions executed, research findings/ observations accurately in lab notr books as per client requirements to ensure data integrity Maintain strict IP confidentiality and adhere to all related policies To prepare final reports as required Ensure high morale and skill development of team: Improve knowledge of organic chemistry (particularly synthesis) / Analytical techniques etc. through ono on one discussions with supervisor/ regular classroom trainings/ project trainings/ further education programs etc. Functional/ Technical Skills Knowledge of Chemistry & Execution Knowledge of Safety Protocols Knowledge of IP & Confidentiality and Data Integrity Ability to conduct cost benefit analysis and optimum usage of resources Required Educational Qualification & Relevant experience Msc (Organic/ Medicinal Chemistry) with 1 - 5 years of relevant experience Additional Requirements Candidates with their research publications in leading journals would be preferred Additional Responsibilities: Reporting Team Reporting Designation: Reporting Department: Educational qualifications preferred Category: Field specialization: Degree: Academic score: Institution tier: Required Certification/s: Required Training/s: Required work experience Industry: Role: Years of experience: Key Performance Indicators: Required Competencies: Required Knowledge: Required abilities Physical: Other: Work Environment Details: Specific requirements Travel: Vehicle: Work Permit: Other details Pay Rate: Contract Types: Time Constraints: Compliance Related: Union Affiliation: Learn more about our end-to-end capabilities Manage consent
Posted 1 week ago
2.0 - 3.0 years
4 - 5 Lacs
Hyderabad
Work from Office
Summary Lead scientific engagement with their Medical Experts. Implement clinical and educational strategies and respond to unsolicited medical enquiries. About the Role Job Location - Mumbai T he MSL is responsible for scientifically engaging, collaborating and aligning with a broad range of external stakeholders to co-create value, address identified patient needs and ultimately change the practice of medicine for better patient access and outcomes. They leverage the right evidence at the right time during their scientific engagements, and identify impactful insights and opportunities that impact and inform the Integrated Product Strategy (IPS), Integrated Evidence Generation Plans, launch excellence roadmap, Patient Journey and medical strategies. MSLs also contribute to innovative healthcare partnerships and implement relevant disease area strategies. They will act as a strategic scientific partner, and collaborate with other Field matrix colleagues (e.g. Value/Market Access, HEOR, clinical research colleagues) to ensure Novartis can support healthcare systems strengthening & improve patient access and outcomes. Key Responsibilities Be a strategic internal partner, gather and leverage insights for an impactful contribution to Patient Journey mapping, launch excellence roadmap, integrated evidence generation plans, integrated product strategy and subsequently the medical strategy. Utilize knowledge of assigned therapeutic area and Novartis compounds to serve as the Medical, Clinical and Scientific expert to field matrix colleagues Identify data gaps, data generation opportunities (including RWE and implementation science, precision medicine), and key unmet needs and opportunities to help improve patient access and outcomes. Ensure appropriate identification and mapping of external stakeholders, aligned to the medical strategy, and in collaboration with other Novartis colleagues. Able to create personalized, flexible engagement strategies and plans, leveraging multiple channels and tailored content to meet the changing needs of external stakeholders Personalize and expand external stakeholder engagement beyond Healthcare Professionals. Support and contribute to innovative partnership models for shared ownership in transforming clinical practice, apply foundational impactful Scientific Engagement principles in stakeholder interactions in alignment with medical strategy and portfolio/pipeline prioritization. Communicate the right evidence to the right stakeholder at the right time, enabling stakeholders to make informed decisions, respond to unsolicited requests for information from stakeholders by sharing appropriate data regarding marketed and pipeline compounds in a timely, compliant, and stakeholder-focused manner. Support Novartis Clinical Trials, adopt and leverage digital channels for a broader, effective, personalized reach and impact, in addition to leading high level impactful scientific events, exchanges and medical education. Manage personal and professional development., manage administrative responsibilities in a timely manner (customer relationship management tool, compliance training and other modules, expense reporting, etc.). Promote and adhere to Ethics and Compliance Professional Practices Policy (P3). Wherever applicable, collaborate with medical teams & HCPs to facilitate MAPs (Managed Access Program) on receipt of unsolicited request. Desirable Requirements: Pharmacist, Masters, or other post-graduate degree in health/life sciences. Doctoral degree preferred (PharmD, PhD, MD), Acts with credibility and clarity of purpose to build and maintain effective and collaborative relationships, working knowledge of the Healthcare System and research procedures as well as the guidelines relevant to the pharmaceutical industry. Experience in a medical function (2-3 years preferred) in at least one therapeutic area. Capable of self-directed learning and having a growth mindset, excellent communication, interpersonal, and influencing skills, with the ability to communicate effectively to a variety of audiences. Application of a curious mindset, employing active listening skills and asking open questions to gain insights and uncover current thinking.,capable to adapt, organize, prioritize, and work effectively and collaboratively on multifunctional teams in a dynamic field-based environment. Proven ability to successfully leverage new technology/digital/IT solutions for effective stakeholder mapping, development, management, and field medical insights gathering. Solid business mentality including innovative, solution-oriented, and critical thinking with performance-focused drive to achieve objectives and execute tactics, Strong personal integrity reflected in all actions and behaviors.
Posted 1 week ago
2.0 - 4.0 years
4 - 6 Lacs
Chennai
Work from Office
As a Consultant, you will work closely with internal and external stakeholders and deliver high quality analytics solutions to real-world Pharma commercial organization s business problems. You will bring deep Pharma / Healthcare domain expertise and use cloud data tools to help solve complex problems Key Responsibilities: Collaborate with internal teams and client stakeholders to deliver Business Intelligence solutions that support key decision-making for the Commercial function of Pharma organizations. Leverage deep domain knowledge of pharmaceutical sales, claims, and secondary data to structure and optimize BI reporting frameworks. Develop, maintain, and optimize interactive dashboards and visualizations using Tableau (primary), along with other BI tools like Power BI or Qlik, to enable data-driven insights. Translate business requirements into effective data visualizations and actionable reporting solutions tailored to end-user needs. Write complex SQL queries and work with large datasets housed in Data Lakes or Data Warehouses to extract, transform, and present data efficiently. Conduct data validation, QA checks, and troubleshoot stakeholder-reported issues by performing root cause analysis and implementing solutions. Collaborate with data engineering teams to define data models, KPIs, and automate data pipelines feeding BI tools. Manage ad-hoc and recurring reporting needs, ensuring accuracy, timeliness, and consistency of data outputs. Drive process improvements in dashboard development, data governance, and reporting workflows. Document dashboard specifications, data definitions, and maintain data dictionaries. Stay up to date with industry trends in BI tools, visualization of best practices and emerging data sources in the healthcare and pharma space. Prioritize and manage multiple BI project requests in a fast-paced, dynamic environment. Qualifications: 2 4 years of experience in BI development, reporting, or data visualization, preferably in the pharmaceutical or life sciences domain. Strong hands-on experience building dashboards using Tableau (preferred), Power BI, or Qlik. Advanced SQL skills for querying and transforming data across complex data models. Familiarity with pharma data such as Sales, Claims, and secondary market data is a strong plus. Experience in data profiling, cleansing, and standardization techniques. Ability to translate business questions into effective visual analytics. Strong communication skills to interact with stakeholders and present data insights clearly. Self-driven, detail-oriented, and comfortable working with minimal supervision in a team-oriented environment. Exposure to data warehousing concepts and cloud data platforms (e.g., Snowflake, Redshift, or BigQuery) is an advantage. Education Bachelor s or Master s Degree (computer science, engineering or other technical disciplines)
Posted 1 week ago
2.0 - 4.0 years
4 - 6 Lacs
Hyderabad
Work from Office
Chryselys Overview Chryselys is a Pharma Analytics & Business consulting company that delivers data-driven insights leveraging AI-powered, cloud-native platforms to achieve high-impact transformations. Chryselys was founded in the heart of Silicon Valley in November 2019 with the vision of delivering high-value business consulting, solutions, and services to clients in the healthcare and life sciences space. We are trusted partners for organizations that seek to achieve high-impact transformations and reach their higher-purpose mission. Chryselys India supports our global clients to achieve high-impact transformations and reach their higher-purpose mission. Our India team focuses on development of Commercial Insights platform and supports client projects. Role Summary As a Consultant, you will work closely with internal and external stakeholders and deliver high quality analytics solutions to real-world Pharma commercial organization s business problems. You will bring deep Pharma / Healthcare domain expertise and use cloud data tools to help solve complex problems Key Responsibilities: Collaborate with internal teams and client stakeholders to deliver Business Intelligence solutions that support key decision-making for the Commercial function of Pharma organizations. Leverage deep domain knowledge of pharmaceutical sales, claims, and secondary data to structure and optimize BI reporting frameworks. Develop, maintain, and optimize interactive dashboards and visualizations using Tableau (primary), along with other BI tools like Power BI or Qlik, to enable data-driven insights. Translate business requirements into effective data visualizations and actionable reporting solutions tailored to end-user needs. Write complex SQL queries and work with large datasets housed in Data Lakes or Data Warehouses to extract, transform, and present data efficiently. Conduct data validation, QA checks, and troubleshoot stakeholder-reported issues by performing root cause analysis and implementing solutions. Collaborate with data engineering teams to define data models, KPIs, and automate data pipelines feeding BI tools. Manage ad-hoc and recurring reporting needs, ensuring accuracy, timeliness, and consistency of data outputs. Drive process improvements in dashboard development, data governance, and reporting workflows. Document dashboard specifications, data definitions, and maintain data dictionaries. Stay up to date with industry trends in BI tools, visualization of best practices and emerging data sources in the healthcare and pharma space. Prioritize and manage multiple BI project requests in a fast-paced, dynamic environment. Qualifications: 2 4 years of experience in BI development, reporting, or data visualization, preferably in the pharmaceutical or life sciences domain. Strong hands-on experience building dashboards using Tableau (preferred), Power BI, and Qlik. Advanced SQL skills for querying and transforming data across complex data models. Familiarity with pharma data such as Sales, Claims, and secondary market data is a strong plus. Experience in data profiling, cleansing, and standardization techniques. Ability to translate business questions into effective visual analytics. Strong communication skills to interact with stakeholders and present data insights clearly. Self-driven, detail-oriented, and comfortable working with minimal supervision in a team-oriented environment. Exposure to data warehousing concepts and cloud data platforms (e.g., Snowflake, Redshift, or BigQuery) is an advantage. Education Bachelor s or Master s Degree (computer science, engineering or other technical disciplines)
Posted 1 week ago
2.0 - 7.0 years
4 - 9 Lacs
Bengaluru
Work from Office
Under general supervision, Prepares and/or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and/or external clients. Provides regulatory support for assigned projects. Essential Functions Acts as a Regulatory Team Member on small, straightforward regulatory projects and/or gets involved in a small single service project, under the guidance of senior staff; Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate; Experienced in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable; Prepares and/or reviews regulatory documentation in area of expertise, as appropriate; Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters; Understands the Scope of Work, deliverables for any given project; May prepare slides and background material for small, straightforward business development meetings under senior guidance and presents in client meetings by phone or in person; May prepare and deliver trainings, as appropriate; Performs other tasks or assignments, as delegated by Regulatory management; Responsible for making minor changes in systems and processes to solve problems where problems faced are not typically difficult or complex; Qualifications Bachelors Degree Degree in Lifescience or related discipline Req Or Masters Degree Degree in Lifescience or related discipline Req At least 2 years relevant experience Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate; Good, solid interpersonal communication (oral and written) and organisation skills; 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; Demonstrates self-motivation and enthusiasm; 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; 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; Applicable certifications and licenses as required by country, state, and/or other regulatory bodies
Posted 1 week ago
3.0 - 6.0 years
5 - 8 Lacs
Hyderabad
Work from Office
Job title: Data Capability and Strategy Lead Location: Hyderabad, India 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 and consumer healthcare. More than 110,000 people in over 100 countries at Sanofi are dedicated to making a difference on patients daily life, wherever they live and enabling them to enjoy a healthier life. 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 R&D Data Office serves as a cornerstone to this effort. Our team is responsible for cross-R&D data strategy, governance, and management. We sit in partnership with Business and Digital, and drive data needs across priority and transformative initiatives across R&D. Team members serve as advisors, leaders, and educators to colleagues and data professionals across the R&D value chain. As an integral team member, you will be responsible for defining how R&Ds structured, semi-structured and unstructured data will be stored, consumed, integrated / shared and reported by different end users such as scientists, clinicians, and more. You will also be pivotal in the development of sustainable mechanisms for ensuring data are FAIR (findable, accessible, interoperable, and reusable). Position Summary: The R&D Data Capability and Strategy Lead serves as the interface between Business and Digital/Data on foundational data capabilities or needs across R&D. This role will be responsible for identification of key use cases across R&D, high level data solutioning (e.g., data strategy, governance/standards, management, infrastructure needs etc), and oversight of day-to-day operations for their specific data capability. Main responsibilities: Drive the development and implementation of R&D s data strategy and governance operating model focusing on data management, data reuse, and integration standards Collaborate with R&D, Digital, IT and Business teams to identify data needs, design innovative solutions, and ensure seamless data flow from ingestion to access Define and maintain standards for data structure, content, metadata, taxonomies, and glossaries, in alignment with Ontology and Common Data Model teams Lead root cause analysis and impact assessments for data-related issues Manage complex data programs and initiatives, ensuring timely delivery, risk mitigation, and alignment with business priorities Promote consistent ways of working and drive change management, including stakeholder communication, training, and adoption Oversee data documentation and act as subject matter expert on master data management Evaluate and recommend new technologies to enhance data governance frameworks, data reuse, and information management Lead and mentor junior data roles (e.g., data modelers, data stewards) involved in end-to-end data activities Define and track KPIs to measure the success and effectiveness of data governance and management initiatives Coordinate with external partners and vendors on data-related initiatives and standards About you E xperience in business data management, information architecture, technology or other related field ,Good knowledge of cross-industry data standards In-depth knowledge in Data Governance functions, processes, technology and deliver the implementation of R&D DG operational model to drive Sanofi s transformation to be data driven organization Good understanding of data storage and data sharing policies and processes knowledge of Data Modelling, and Ontology Management is recommended Basic programming skills. Strong familiarity with pharma R&D processes and technology in particular in the development area: CMC and Clinical Ability to build business relationships and understand end-to-end data use and needs Diplomatic and stakeholder management skills across business, technology, and partners A deep understanding of the data processes and requirements, particularly in R&D with knowledge of Clinical trials data Demonstrated strong attention to detail, quality, time management and customer focus Excellent written and oral communications skills Strong networking, influencing and negotiating skills and superior problem-solving skills Demonstrated willingness to make decisions and to take responsibility for such Excellent interpersonal skills (team player) People management skills either in matrix or direct line function Education: Bachelors or Masters degree in Computer Science, Business, Engineering, Information Technology ,Languages: English
Posted 1 week ago
5.0 - 10.0 years
7 - 12 Lacs
Pune
Work from Office
Job Title: GitHub Admin L3 Department: DevOps / IT Infrastructure Location: Pune Experience Level: 5+ years (with 2+ years in GitHub Administration) Job Type: Full-time Job Summary: We are seeking a highly skilled GitHub Admin Level 3 to manage, maintain, and optimize our GitHub Enterprise environment. This role involves collaborating with engineering, security, and DevOps teams to ensure smooth operation, access control, security enforcement, automation, and policy compliance within GitHub and related CI/CD systems. Key Responsibilities: Administration & Configuration: o Administer GitHub Enterprise Cloud/Server (GHEC/GHES) including users, organizations, repositories, and teams. o Manage OAuth and SAML integrations for authentication and identity access. o Configure branch protection rules, secrets, workflows, and repository settings. o Apply governance policies and manage role-based access controls (RBAC). Security & Compliance: o Enforce security best practices using GitHub Advanced Security (code scanning, secret scanning, dependency review). o Audit and manage GitHub Actions runners (hosted/self-hosted). o Monitor and mitigate compliance issues such as unused repositories, license violations, or policy breaches. Automation & Integrations: o Develop and maintain GitHub Actions workflows and integrations with CI/CD tools like Jenkins, Azure DevOps, or GitLab. o Automate onboarding/offboarding processes using GitHub CLI or APIs. o Integrate third-party tools like Jira, Slack, SonarQube, or Artifactory. Support & Troubleshooting: o Serve as L3 escalation point for GitHub-related issues. o Resolve technical incidents related to GitHub access, permissions, workflows, and performance. o Coordinate with GitHub support for platform-level issues. Monitoring & Reporting: o Create dashboards and reports on usage, compliance, and performance metrics. o Monitor GitHub API usage and rate limits. o Track license consumption and manage billing insights. Required Skills & Qualifications: Bachelors degree in Computer Science, Information Technology, or a related field. 5+ years of experience in DevOps or system administration. 2+ years of hands-on experience managing GitHub Enterprise (Cloud or Server). Proficient with Git, GitHub CLI, GitHub REST/GraphQL APIs. Experience with scripting languages (Python, Bash, PowerShell). Strong understanding of CI/CD pipelines and tools. Knowledge of IAM principles and SSO (e.g., Okta, Azure AD). Familiar with security best practices in code repositories. Preferred Qualifications: GitHub Certified Administrator or DevOps Engineer. Experience in managing large-scale enterprise GitHub environments. Experience with GitHub Copilot, GitHub Advanced Security, or GitHub Connect. Familiarity with compliance standards (SOC2, ISO 27001, etc.). Previous experience working in Agile/Scrum environments. Soft Skills: Strong analytical and troubleshooting skills. Excellent communication and documentation abilities. Ability to work independently and as part of a distributed team. Security- and detail-oriented mindset. Employee Benefits: Group Medical Insurance Cab facility Meals/snacks Continuous Learning Program Company Profile: Stratacent is a Global IT Consulting and Services firm, headquartered in Jersey City, NJ, with global delivery centres in Pune and Gurugram plus offices in USA, London, Canada and South Africa. We are a leading IT services provider focusing in Financial Services, Insurance, Healthcare and Life Sciences. We help our customers in their transformation journey and provides services around Information Security, Cloud Services, Data and AI, Automation, Application Development and IT Operations. URL - http://stratacent.com Stratacent India Private Limited is an equal opportunity employer and will not discriminate against any employee or applicant for employment on the basis of race, color, creed, religion, age, sex, national origin, ancestry, handicap, or any other factor protected by law. ",
Posted 1 week ago
7.0 - 13.0 years
6 - 11 Lacs
Hyderabad
Work from Office
Career Category Information Systems Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Specialist IS Engineer What you will do Amgen India will be an integral part in driving growth & innovation, improving efficiency and creating enterprise value supporting our mission To Serve Patients . We are seeking a highly skilled Specialist IS Engineer Visualization Role to join our Global Medical Data and Analytics team and lead the technology ecosystem for enhancing Amgen s analytics and Visualization capability. This role will be be part of the development team under the Scaled Agile Framework (SAFe) Medical Data Analytics and Insights Product Team and primarily focus on delivering Analytics capabilities across Global Medical business organization. The selected individual will engage with business users, validation engineers, product owner, architects and the members of the development team to develop and deliver analytics needs and enhancements. This role requires expertise in BI reporting tools like Tableau, Power BI and ability to develop technical solutions using Datalake and ETL technology platforms. Additionally, collaboration with various global teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a strong technical background in the end-to-end software development lifecycle and be a Scaled Agile practitioner. This role demands the ability to drive and deliver against key organizational strategic initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Additionally, this role will bridge the gap between IT and Amgen Medical across the broader scientific data/technology ecosystem. The ideal candidate will analyze, design, and support the implementation of software solutions that meet the unique needs of our medical teams. They will provide day to day operations, data standardization, ad hoc query, reporting, technical support, training, data Roles & Responsibilities: As a specialist and Senior Visualization Developer Lead the design, development, and deployment of advanced data visualization solutions for Global Medical teams, enabling actionable insights across diverse business capabilities. Develop interactive dashboards and analytical reports using industry-standard tools (e. g . , Tableau, Power BI ) to visualize complex medical data for various stakeholders, ensuring clarity and accuracy. Develop visualization prototypes for building interactive applications using latest frameworks like React js . Drive innovation in data visualization by introducing advanced techniques (e. g. , predictive analytics, dynamic storytelling) to highlight trends and opportunities. Monitor and enhance the performance of visualization tools, ensuring optimal load times and usability. Ensure data integrity, quality, and compliance with regulatory standards, such as HIPAA and GDPR. Oversee the implementation of automated data validation frameworks, ensuring consistency across datasets and reducing errors. Partner with cross-functional teams to understand business requirements and translate them into scalable visualization solutions. Present data insights and visualization solutions to senior leadership, enabling data-driven decision-making across the organization. Train and mentor team members and business users on the effective use of visualization tools and analytics best practices. Manage and mentor a team of data visualization experts and analysts, fostering a culture of collaboration and innovation. Establish and monitor KPIs for the visualization team to ensure alignment with business goals and objectives. Drive cross-functional collaboration with engineering, data science, and business teams to streamline workflows and enhance efficiency. Drive the implementation of reusable, scalable frameworks for visualization solutions to support global reporting needs. Support ad-hoc and strategic reporting requests with customized data visualizations tailored to business needs. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Technical Expertise & Innovation Stay updated with emerging trends and tools in data visualization and analytics, incorporating innovative solutions into the teams workflows. Advocate for the adoption of cutting-edge tools and methodologies to elevate the organizations visualization capabilities. Collaborate on the development of a centralized data lake and ensure alignment with enterprise architecture standards. An ongoing commitment to learning and staying at the forefront of AI/ML advancements Key Skills Required Expertise in visualization tools such as Tableau, Power BI, or React js equivalent. Proficiency in SQL, Python, R, or other data analysis programming languages. Strong understanding of medical data models, including Field Medical, Medinfo, and SciComm frameworks. Excellent communication and stakeholder management skills. Strong project management skills, with experience leading cross-functional teams. Basic Qualifications: Doctorate degree / Masters degree / Bachelors degree and 8 to 13 years of Information Systems experience Preferred Qualifications: Bachelor s or Master s degree in Data Science, Computer Science, Analytics, Business Administration, or a related field. 7+ years of experience in data analytics, visualization, or business intelligence, preferably within the pharmaceutical, life sciences, or healthcare industry. Demonstrated experience in managing global data projects and collaborating with cross-functional teams in a matrixed organization. Advanced certifications in data visualization tools (e. g. , Tableau Certified Professional, Microsoft Power BI Certification). Familiarity with cloud platforms such as AWS, Azure, or GCP, and experience in integrating data visualization solutions with cloud-based architectures. Must-Have Skills: Excellent communication and interpersonal skills, with the ability to convey technical information to non-technical users Ability to work collaboratively with cross-functional teams and manage multiple tasks simultaneously Strong analytical and problem-solving skills to interpret complex data and provide actionable insights Strong skills in analyzing and modeling large datasets, with expertise in creating aggregate data models and enabling ad-hoc reporting. Good-to-Have Skills: Work experience in the biotechnology or pharmaceutical industry. Experience using and adopting Scaled Agile Framework (SAFe) Ability to work effectively in a fast-paced, dynamic environment. An ongoing commitment to learning and staying at the forefront of AI/ML advancements. Professional Certifications SAFe for Teams certification (preferred) Soft Skills: Exceptional collaboration and communication skills. Ability to manage multiple priorities successfully. Team-oriented with a focus on achieving team goals. Strong presentation and public speaking skills. Strong ability to inspire and lead teams, fostering collaboration and accountability. Proactive approach to identifying challenges and implementing data-driven solutions effectively. Proven ability to work with cross-functional and multicultural teams to deliver on shared goals. Flexibility to manage evolving priorities in a fast-paced, dynamic environment. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers. amgen. com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .
Posted 1 week ago
4.0 - 6.0 years
9 - 13 Lacs
Bengaluru
Work from Office
Job Description Summary Compliance and Validation Hands-on experience in the role of Compliance and Validation Well-versed with GxP, GDPR, FDA, Part 11, and standard regulations Knowledge of 21 CFR part 11, GxP regulations, GAMP 5 guidelines System validation in alignment with GxP and regulatory requirements Good knowledge of assessing Traceability gaps, improper verification of requirements, improper attached evidences, and raised observations for each deviation Hands-on experience in reviewing validation artifacts, and quality reviews System Life Cycle and Methodologies Well-versed with System Life Cycle Hands-on experience with Validation approach, Agile methodology, AIML concepts Testing/Validation Experience Exposure in reviewing Test Plans, Test Summary Reports Development of System Validation Lifecycle documents Risk Analysis, Validation Plan, Validation Summary Report Preparation and Review of validation deliverables (Validation plan, Functional Risk Assessment, Requirement Traceability Matrix, Qualification Summary Report) Good knowledge about the defect life cycle Tools and Technologies - Hands-on experience with tools like HP ALM, Jira, TrackWise, Veeva, QMS systems Quality Management - Knowledge of Quality Management System (QMS) Domain Knowledge - Healthcare, CRO, Life Sciences domain knowledge Good to Have Skills : SaaS Validation and Process -Familiarity with SaaS validation and process System Validation Analysis and development of System Validation Lifecycle documents Risk Analysis of system and requirements. Compliance and Audits - IT and CSV compliance and audit of third-party vendors, Participation in internal audits and/or regulatory audits to represent CSV and IT compliance. Vendor Management - Vendor evaluation and qualification Testing/Validation Process - Knowledge about Testing/Validation process, automation Software Development Life Cycle (SDLC) - Good knowledge about the SDLC process Data Management and Risk-Based Approach - Good knowledge on data management, risk-based approach Documentation - Experience in authoring and improving SOPs, work instructions, and templates 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
Posted 1 week ago
3.0 - 6.0 years
9 - 13 Lacs
Hyderabad
Work from Office
Lead Analyst - Compensation and Benefits About Providence Providence, one of the US s largest not-for-profit healthcare systems, is committed to high quality, compassionate healthcare for all. Driven by the belief that health is a human right and the vision, Health for a better world , Providence and its 121, 000 caregivers strive to provide everyone access to affordable quality care and services. Providence has a network of 51 hospitals, 1, 000+ care clinics, senior services, supportive housing, and other health and educational services in the US. Providence India is bringing to fruition the transformational shift of the healthcare ecosystem to Health 2. 0. The India center will have focused efforts around healthcare technology and innovation, and play a vital role in driving digital transformation of health systems for improved patient outcomes and experiences, caregiver efficiency, and running the business of Providence at scale. Why Us Best In-class Benefits Inclusive Leadership Reimagining Healthcare Competitive Pay Supportive Reporting Relation How is this team contributing to the vision of Providence At Providence India, we are committed to building a high-performance, people-first culture. As we expand our footprint and enhance our total rewards philosophy, we are seeking a passionate Compensation & Benefits professional to support our core C&B programs for Providence India. This role will play a key part in ensuring competitiveness, compliance, and alignment of our rewards framework with business priorities. This is an individual contributor role responsible for supporting the compensation and benefits strategy and execution for the India region. The ideal candidate will have prior experience in Tech and IT industries, Global Capability Centers (GCCs), or similar knowledge-based industries. Exposure to healthcare or pharmacy domain will be an added advantage. What will you be responsible for Compensation: Manage annual compensation processes including salary planning, merit reviews, promotions, and bonus cycles. Conduct compensation, benchmarking and external market analysis. Maintain internal job architecture, salary ranges, and pay equity frameworks. Evaluate and support pay decisions for new hires, internal movements, and off-cycle adjustments. Support compensation communication, manager enablement, and analytics. Benefits: Administer employee benefits across insurance, wellness, leave, and retirement programs. Drive renewal negotiations, vendor evaluations, and utilization analysis. Ensure adherence to Indian statutory requirements (PF, ESIC, Gratuity, etc. ) and regulatory updates. Recommend benefit enhancements based on employee feedback and market trends. Analytics & Systems: Maintain compensation and benefits data integrity across HRIS and internal systems (e. g. , SAP SF, Workday). Generate reports and cost related insights for leadership, audits, and workforce planning needs. Collaborate with people analytics and in-house technology teams, external IT partners, Payroll, and HRBPs to ensure data alignment. Stakeholder Management & Projects: Serve as a subject matter expert for business and HR stakeholders on all C&B matters. Support or lead regional projects (e. g. , salary benchmarking, policy harmonization, job levelling). Provide consultative support to HR business partners for complex C&B cases and policy interpretation. Who are we looking for 6 9 years of experience in Compensation & Benefits roles, preferably within IT Services, GCCs/Captives, consulting, or shared services environments. MBA in HR or related post-graduate is preferred. Solid understanding of Indian compensation frameworks, benefits design, and compliance requirements. Strong analytical, interpersonal, and communication skills. Proficiency in Excel, HR analytics, and familiarity with HRIS tools such as SAP SuccessFactors, or Workday. Experience working in or supporting healthcare, pharma, or life sciences firms is a plus. Why Join Us: Contribute to shaping strategic C&B frameworks in a fast-evolving and people-focused organization. Work with dynamic teams across regions and business lines. Access to professional development, cross-functional projects, and a culture that values expertise and impact. Providence s vision to create Health for a Better World aids us to provide a fair and equitable workplace for all in our employment, whether temporary, part-time or full time, and to promote individuality and diversity of thought and background, and acknowledge its role in the organization s success. This makes us committed towards equal employment opportunities, regardless of race, religion or belief, color, ancestry, disability, marital status, gender, sexual orientation, age, nationality, ethnic origin, pregnancy, or related needs, mental or sensory disability, HIV Status, or any other category protected by applicable law. In furtherance to our mission in building a more inclusive and equitable environment, we shall, from time to time, undertake programs to assist, uplift and empower underrepresented groups including but not limited to Women, PWD (Persons with Disabilities), LGTBQ+ (Lesbian, Gay, Transgender, Bisexual or Queer), Veterans and others. We strive to address all forms of discrimination or harassment and provide a safe and confidential process to report any misconduct. Contact our Integrity hotline also, read our Code of Conduct . Apply now Find similar jobs:
Posted 1 week ago
7.0 - 13.0 years
25 - 30 Lacs
Hyderabad
Work from Office
Career Category Information Systems Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Specialist IS Engineer What you will do Amgen India will be an integral part in driving growth & innovation, improving efficiency and creating enterprise value supporting our mission To Serve Patients . We are seeking a highly skilled Specialist IS Engineer Visualization Role to join our Global Medical Data and Analytics team and lead the technology ecosystem for enhancing Amgen s analytics and Visualization capability. This role will be be part of the development team under the Scaled Agile Framework (SAFe) Medical Data Analytics and Insights Product Team and primarily focus on delivering Analytics capabilities across Global Medical business organization. The selected individual will engage with business users, validation engineers, product owner, architects and the members of the development team to develop and deliver analytics needs and enhancements. This role requires expertise in BI reporting tools like Tableau, Power BI and ability to develop technical solutions using Datalake and ETL technology platforms. Additionally, collaboration with various global teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a strong technical background in the end-to-end software development lifecycle and be a Scaled Agile practitioner. This role demands the ability to drive and deliver against key organizational strategic initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Additionally, this role will bridge the gap between IT and Amgen Medical across the broader scientific data/technology ecosystem. The ideal candidate will analyze, design, and support the implementation of software solutions that meet the unique needs of our medical teams. They will provide day to day operations, data standardization, ad hoc query, reporting, technical support, training, data Roles & Responsibilities: As a specialist and Senior Visualization Developer Lead the design, development, and deployment of advanced data visualization solutions for Global Medical teams, enabling actionable insights across diverse business capabilities. Develop interactive dashboards and analytical reports using industry-standard tools (e. g . , Tableau, Power BI ) to visualize complex medical data for various stakeholders, ensuring clarity and accuracy. Develop visualization prototypes for building interactive applications using latest frameworks like React js . Drive innovation in data visualization by introducing advanced techniques (e. g. , predictive analytics, dynamic storytelling) to highlight trends and opportunities. Monitor and enhance the performance of visualization tools, ensuring optimal load times and usability. Ensure data integrity, quality, and compliance with regulatory standards, such as HIPAA and GDPR. Oversee the implementation of automated data validation frameworks, ensuring consistency across datasets and reducing errors. Partner with cross-functional teams to understand business requirements and translate them into scalable visualization solutions. Present data insights and visualization solutions to senior leadership, enabling data-driven decision-making across the organization. Train and mentor team members and business users on the effective use of visualization tools and analytics best practices. Manage and mentor a team of data visualization experts and analysts, fostering a culture of collaboration and innovation. Establish and monitor KPIs for the visualization team to ensure alignment with business goals and objectives. Drive cross-functional collaboration with engineering, data science, and business teams to streamline workflows and enhance efficiency. Drive the implementation of reusable, scalable frameworks for visualization solutions to support global reporting needs. Support ad-hoc and strategic reporting requests with customized data visualizations tailored to business needs. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Technical Expertise & Innovation Stay updated with emerging trends and tools in data visualization and analytics, incorporating innovative solutions into the teams workflows. Advocate for the adoption of cutting-edge tools and methodologies to elevate the organizations visualization capabilities. Collaborate on the development of a centralized data lake and ensure alignment with enterprise architecture standards. An ongoing commitment to learning and staying at the forefront of AI/ML advancements Key Skills Required Expertise in visualization tools such as Tableau, Power BI, or React js equivalent. Proficiency in SQL, Python, R, or other data analysis programming languages. Strong understanding of medical data models, including Field Medical, Medinfo, and SciComm frameworks. Excellent communication and stakeholder management skills. Strong project management skills, with experience leading cross-functional teams. Basic Qualifications: Doctorate degree / Masters degree / Bachelors degree and 8 to 13 years of Information Systems experience Preferred Qualifications: Bachelor s or Master s degree in Data Science, Computer Science, Analytics, Business Administration, or a related field. 7+ years of experience in data analytics, visualization, or business intelligence, preferably within the pharmaceutical, life sciences, or healthcare industry. Demonstrated experience in managing global data projects and collaborating with cross-functional teams in a matrixed organization. Advanced certifications in data visualization tools (e. g. , Tableau Certified Professional, Microsoft Power BI Certification). Familiarity with cloud platforms such as AWS, Azure, or GCP, and experience in integrating data visualization solutions with cloud-based architectures. Must-Have Skills: Excellent communication and interpersonal skills, with the ability to convey technical information to non-technical users Ability to work collaboratively with cross-functional teams and manage multiple tasks simultaneously Strong analytical and problem-solving skills to interpret complex data and provide actionable insights Strong skills in analyzing and modeling large datasets, with expertise in creating aggregate data models and enabling ad-hoc reporting. Good-to-Have Skills: Work experience in the biotechnology or pharmaceutical industry. Experience using and adopting Scaled Agile Framework (SAFe) Ability to work effectively in a fast-paced, dynamic environment. An ongoing commitment to learning and staying at the forefront of AI/ML advancements. Professional Certifications SAFe for Teams certification (preferred) Soft Skills: Exceptional collaboration and communication skills. Ability to manage multiple priorities successfully. Team-oriented with a focus on achieving team goals. Strong presentation and public speaking skills. Strong ability to inspire and lead teams, fostering collaboration and accountability. Proactive approach to identifying challenges and implementing data-driven solutions effectively. Proven ability to work with cross-functional and multicultural teams to deliver on shared goals. Flexibility to manage evolving priorities in a fast-paced, dynamic environment. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers. amgen. com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .
Posted 1 week ago
3.0 - 8.0 years
11 - 15 Lacs
Bengaluru
Work from Office
IT QA Senior Expert Job Details | Teva Pharmaceuticals Find a Career With Purpose at Teva Search by Postal Code Area of Interest Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: IT QA Senior Expert Jul 22, 2025 Bangalore, India, 560064 Who we are The opportunity This section is where we attract the attention of potential candidates and sell the role. How has the role come aboutWhat makes it appealingWhat are the key responsibilitiesHow is the role better with Teva than with another companyWherever possible, we should bring through the essence of our EVP pillars, i. e. , we care, we re in it together, and we make work fulfilling. How you ll spend your day The role includes the following responsibilities to support services offered by Global Operations: Provide validation support for IT projects by reviewing and approving validation deliverables from a Quality perspective, including specifications, test plans, test results, and change controls. Support system lifecycle activities by creating, reviewing, and maintaining validation documentation in compliance with GxP and internal standards. Ensure data integrity (ALCOA+) is embedded in system design, implementation, and operation. Collaborate with IT, Quality, and Business stakeholders to ensure alignment on validation and compliance expectations. Support complex system implementations and upgrades, applying a risk-based approach to validation and compliance. Contribute to the development and maintenance of validation procedures, templates, and strategic documentation. Provide informal guidance and training to project teams and stakeholders on validation practices, regulatory expectations, and internal policies. Actively contribute to the continuous improvement and knowledge sharing within the IT Q&C team and across the organization. The role also includes the following responsibilities to support services offered by the IT Q&C department: Support internal and external audits (regulatory, customer, supplier) and ensure audit readiness. Contribute to the global supplier qualification process by reviewing validation and compliance documentation. Support the management and maintenance of procedures, guidelines, and training materials. Assist in infrastructure qualification and inventory management activities. Participate in IT Q&C process improvement initiatives. Your experience and qualifications Bachelor s or Master s degree in Information Technology, Life Sciences, or a related field. Minimum of 3 years of professional experience in Computer System Validation (CSV) or SDLC activities in a GxP-regulated environment. Experience in IT system implementation, particularly in QC and EDMS domains. In-depth knowledge of GxP compliance requirements from EMA, FDA, and other relevant regulatory bodies. Strong understanding of risk-based validation and compliance approaches. Proven experience in CSV within regulated environments. High attention to detail and results-oriented mindset. Excellent command of English (written and spoken). Strong interpersonal, communication, and presentation skills. Ability to work effectively in a global, cross-functional team environment. Enjoy a more rewarding choice Make a difference with Teva Pharmaceuticals Team Manager Quality & Mfg. Systems Already Working @TEVA The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner. Teva s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
Posted 1 week ago
1.0 - 3.0 years
3 - 5 Lacs
Pune
Work from Office
Billing Analyst At Ecolab, you can help take on some of the world s most meaningful challenges, delivering critical insights and innovative solutions to help our customers achieve clean water, safe food, abundant energy and healthy environments. With our worldwide reach and ambitious growth plans, you will have the opportunity to own your future and impact what matters. Are you ready to make an impact What s in it For You: You will join a growth company offering a competitive salary and benefits. The ability to make an impact and shape your career with a company that is passionate about growth. The support of an organization that believes it is vital to include and engage diverse people, perspectives and ideas to achieve our best. Feel proud each day to work for a company that provides clean water, safe food, abundant energy and healthy environments. Job Description: Ecolab is seeking a Billing Analyst supporting our Global Business Services team in Pune, India. This role will operate in a UK shift. The Billing department is responsible for ensuring sales orders and contracted services are billed in a timely and accurate manner. This department s responsibility includes daily review and resolution of blocked sales orders, processing of documents blocked from posting to accounting, set-up of new list pricing, set-up of campaigns per direction of marketing, and execution of all SOX controls tied to pricing and corrections. The primary objective of the Billing Analyst is to execute the daily invoice audit to ensure all invoices generated were distributed and accurate, review and resolve errors identified on the VFX3 report, and maintain and set-up list pricing and campaigns. This position has a high level of responsibility in ensuring SOX controls are executed effectively, pricing and campaigns are set-up accurately and timely and acting as the subject matter expert for billing processes. The Billing Analyst is expected to embrace the Ecolab culture and ensure the billing department consistently meets service level agreements and timely revenue recognition What will you do: Complete daily invoice audit to ensure invoices are accurate and distributed Ensure all appropriate approvals were obtained prior to processing corrections, and enter corrections based on department guidance Administer invoice updates and corrections for billing activities Provide expert insight into billing processes operational effectiveness Establish strong working relationships with division finance and CBC peers Perform problem solving analysis and implement corrective action when needed Prepare and maintain process documentation Compile and publish monthly activity tracking reporting Assist with validating RQF and list pricing uploads Provide prompt follow-up actions to internal and external inquiries and issues Respond timely to incoming communications Adhere to company and department policies and procedures Minimum Qualifications: Degree in Business, Accounting, Finance, or related field Master s Degree strongly preferred A minimum of 4 years of related experience Proficient in Microsoft Office application Excel Fluent in English Fluent in Spanish preferred Preferred Qualifications: Ability to work independently in a fast-paced environment Demonstrated problem solving ability to resolve problems independently and take appropriate action in a timely manner Previous analytical experience with high aptitude for research, analysis, and problemsolving. Follow us on LinkedIn@Ecolab, Twitter@Ecolab, Instagram@Ecolab_Inc and Facebook @Ecolab.
Posted 1 week ago
0.0 - 1.0 years
2 - 3 Lacs
Visakhapatnam, Nagpur, Hyderabad
Work from Office
Coordinate and manage clinical trials from initiation to completion, ensuring compliance with regulatory guidelines and study protocols Recruit, screen, and enroll study participants while maintaining accurate documentation and records Required Candidate profile Maintain study supplies, track data collection, and support data analysis, ensuring high-quality and ethical research practices throughout the study
Posted 1 week ago
0.0 - 1.0 years
2 - 5 Lacs
Hyderabad/Secunderabad, Pune, Bengaluru
Work from Office
Should have knowledge in clinical research studies Monitoring of Clinical studies conducted at various CROs located globally as per ICH/GCP, applicable regulatory requirements, protocols and SOPs. Perform Site visits (i.e. Site Selection Visit) Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.
Posted 1 week ago
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