Senior Medical Data Reviewer
HyderabadFull-time3–5 yrsPosted 2 days ago
Mid-level pharma role at Amgen in Hyderabad. Needs 3–5 years and an MBBS or diploma.
About the role
We combine science, technology, and the capabilities of our people to research, develop, and deliver innovative medicines. The Senior Medical Data Reviewer is accountable and responsible for the study-level MDR workstream for assigned study or studies.
What you'll do
- Define, maintain, and deliver the study MDR strategy from start-up through conduct, interim analyses, database lock, and closeout
- Translate protocol objectives, study risks, critical-to-quality factors, and emerging evidence into scientifically sound IDRP inputs, prioritized review activities
- Provide medical-interpretation inputs to a fit-for-purpose Medical Monitoring Plan within MDR scope as per IDRP
- Integrate participant-level and aggregate evidence, assess complex findings, and recommend proportionate follow-up or escalation
- Plan and coordinate MDR review cycles, define task-level expectations for assigned reviewers
What you need
- Clinical research
- Pharmacovigilance
- Documentation