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 sells medicines that change lives for people, with severe illnesses. The company is run by doctor scientists. It has a history of changing science into real treatments that have been approved. Regeneron works on eye diseases, cancer, heart problems, brain diseases and rare illnesses. A lot of its research was done in its labs.
Job Summary
This hybrid role sits within Regenerons Global Patient Safety team, based in Hyderabad. As a Senior Manager, Medical Review, Senior Manager, Medical Review will lead the review of safety cases to ensure accuracy and inspection readiness before submission. Senior Manager, Medical Review will work closely with triage, pharmacovigilance, risk management and clinical development teams, across 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.
Work closely with triage, pharmacovigilance and clinical teams to prepare inspection- documentation.
Act as the expert for assigned compounds handling difficult case issues and finding solutions.
Help develop operating procedures improve processes and support the use of new technologies, like AI.
Guide junior reviewers to ensure medical standards stay consistent across all work.
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 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
Regeneron does not publicly list a fixed salary for the Senior Manager Medical Review role in India typically range from ₹15 Lakhs to ₹20 Lakhs per year.
Career Development
This role offers exposure to global pharmacovigilance leadership in a fast growing science driven biotechnology company. Regeneron supports long term growth through mentorship opportunities and a real commitment to advancing careers, in safety.
How to Apply
Visit our job portal and search for the Senior Manager, Medical Review role in Regeneron.
Click on the listing to see the job details.
Enter your information and upload your resume.
Submit your application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
Salary Insights
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Hiring Trends
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