BioSpace
Website:
biospace.com
Job details:
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, Pharmacovigilance Medical Review, India to join our Global Patient Safety team, supporting our global development programs and marketed products in a hybrid role. In this role, you will lead the medical review of safety cases to ensure every report is scientifically sound and inspection-ready before health authority submission, while collaborating with triage, pharmacovigilance, risk management, and clinical development partners across India, the US, and the EU. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & where: Hyderabad (Hybrid)
Discover Your Role
- Act as team lead, owning end-to-end case quality from coding through causality to final company comment
- Perform and oversee medical review of ICSRs within defined time standards, ensuring accuracy in Argus
- Author and review case narratives, analysis of similar events, and company causality rationale
- Code adverse events and medical history using MedDRA in line with global safety standards
- Partner with triage, PV, risk management, and clinical development teams on inspection-ready documentation
- Serve as the medical resource for assigned compounds, resolving and escalating complex case issues
- Drive SOP development, process improvement, and integration of new technologies including AI
- You mentor Managers and junior reviewers to ensure consistent application of medical and regulatory standards
This Role Requires
- MD or MBBS with active registration, or eligibility for registration, with the relevant Indian professional regulatory body
- Minimum 810 years of pharmacovigilance experience with hands-on ICSR medical review, including narrative authoring, causality assessment, and expectedness determination
- Strong knowledge of ICH E2A, E2B, and E2D guidelines and FDA/EMA pharmacovigilance regulations
- Proficiency with Argus Safety or an equivalent safety database and MedDRA coding
- Sound clinical judgment with the ability to assess complex cases and communicate reasoning clearly in writing
- Experience within global development programs or on marketed products preferred
- Exposure to AI or generative AI tools in pharmacovigilance or clinical documentation a plus
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
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