Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with reliable 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 rapid-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 skilled regulatory body
Minimum 8–10 years of pharmacovigilance experience with hands-on ICSR medical review, including narrative authoring, causality assessment, and expectedness determination
Robust knowledge

📌 Senior Manager Medical Review Hyderabad (India)
🏢 Regeneron Pharmaceuticals
📍 India