Lead Medical Data Reviewer
HyderabadFull-time5–8 yrsPosted 2 days ago
Senior consulting role at Amgen in Hyderabad. Needs 5–8 years and a diploma or MBBS.
About the role
We combine science, technology, and the capabilities of our people to research, develop, and deliver innovative medicines. The Lead Medical Data Reviewer is accountable and responsible for project- or molecule-level MDR strategy and integrated outputs across assigned studies in the therapeutic areas.
What you'll do
- Establish and maintain the project or molecule MDR strategy, across assigned studies, aligned with development objectives, product risks, critical-to-quality factors
- Set scientific expectations for IDRP strategy and inputs across studies; ensure approaches are consistent where useful and tailored to phase, indication, modality
- Provide cross-study medical-interpretation inputs that support risk based fit-for-purpose Medical Monitoring Plans as per IDRP
- Synthesize participant-level and aggregate patterns across studies to form an integrated project or molecule risk view and recommend follow-up, trade-offs, or escalation
- Resolve complex MDR issues that cross study boundaries by bringing together the Medical Monitor, Clinical Scientist, Safety, Data Management, Clinical Operations
What you need
- Change management
- Research
- Pharmacovigilance