Senior Manager, Medical Review
Senior Manager, Medical Review
Regeneron
Job description
Looking to build a career in pharmacovigilance medical review? Explore this Senior Manager, Medical Review role at Regeneron in Hyderabad.
Company Description
Regeneron is a biotechnology company that creates, builds and brings to market medicines that change lives for people, with serious illnesses. The company is run by doctor scientists. It has a history of taking science and making real approved treatments. Regenerons efforts cover eye diseases, cancer, heart problems, brain diseases and rare illnesses. A lot of its drug development happened in its labs.
Job Summary
Regenerons Global Patient Safety team, located in Hyderabad. As a Senior Manager, Medical Review you will lead the review of safety cases to make sure they are accurate and ready for inspection before submission. Your work will involve collaboration with triage, pharmacovigilance, risk management and clinical development teams, in India, the US and the EU supporting both trial and marketed products.
Key Responsibilities
Act as team lead, owning full case quality from coding to final review.
Perform and oversee medical review of ICSRs within required time standards.
Author and review case narratives, event comparisons, and causality assessments.
Code adverse events and medical history using MedDRA standards.
Partner with triage, pharmacovigilance, and clinical teams on inspection ready documentation.
Serve as the medical resource for assigned compounds, resolving complex case issues.
Support SOP development, process improvement, and adoption of new technologies, including AI.
Mentor managers and junior reviewers to keep medical standards consistent.
Educational Qualification
MD or MBBS, with active registration, or eligibility for registration, with the relevant Indian professional regulatory body.
Skills Required
8 to 10 years of pharmacovigilance experience, including hands on ICSR medical review.
Strong knowledge of ICH E2A, E2B, and E2D guidelines, along with FDA and EMA regulations.
Proficiency with Argus Safety or a similar safety database, along with MedDRA coding.
Strong clinical judgment to assess complex cases and explain reasoning clearly.
Experience within global development programs or marketed products is preferred.
Exposure to AI or generative AI tools in pharmacovigilance is a plus.
Salary Structure
The estimated annual salary for a Senior Manager, Medical Review at Regeneron in Hyderabad, India ranges from approximately ₹20 Lakhs to ₹30 Lakhs per year.
Career Development
This role offers strong exposure to global pharmacovigilance leadership within a fast growing, science driven biotechnology company. Regeneron also supports long term growth through mentorship opportunities and a genuine commitment to advancing careers in medical safety.
How to Apply
Visit our job portal and search for the Senior Manager, Medical Review role - Regeneron.
Click on the job posting to read all the details, about the job.
Fill in your details. Upload your updated resume.
Send your application.
Education
Postgraduate Degree (Master's/PhD)
Key Skills
Market insights & trends
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