Hybrid Pharmacovigilance Job at Regeneron
Are you an experienced Pharmacovigilance professional looking to lead global drug safety reviews with a leading biotechnology company? If you have extensive experience in ICSR medical review, pharmacovigilance, and regulatory compliance, this Senior Manager Medical Review role at Regeneron could be your next career milestone. This Hybrid Pharmacovigilance Job opportunity in Hyderabad allows you to lead medical safety case reviews, collaborate with global development teams, and contribute to life-changing medicines.
About the Company:
Regeneron is a globally recognized biotechnology company dedicated to discovering, developing, and delivering life-changing medicines for people with serious diseases. Through science, innovation, and cutting-edge research, Regeneron develops therapies across multiple therapeutic areas. The company fosters a collaborative and inclusive work culture, enabling employees to contribute to global development programs while making a meaningful impact on patient health worldwide.
Job Details:
- Job Title: Senior Manager Medical Review
- Job ID: R47767
- Company: Regeneron
- Department: Global Development
- Location: Hyderabad, Telangana, India
- Work Mode: Hybrid
- Employment Type: Full-Time
- Function: Pharmacovigilance Medical Review
- Industry: Biotechnology / Pharmaceutical
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
Requirements for the Hybrid Pharmacovigilance Job:
- 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
