Senior Manager Medical Review

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 8–10 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.