Career Category
Medical Services
Job Description
ABOUT AMGEN
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

Senior Medical Data Reviewer

In this vital role, the Senior Medical Data Reviewer is accountable for quality oversight of the Medical Data Reviewer (MDR) team across multiple Therapeutic Areas (TAs). This role is accountable for end-to-end clinical data review quality and delivery. The Senior Medical Data Reviewer provides people leadership to Medical Data Reviewers, serves as the point of escalation for complex clinical data issues, and partners cross-functionally to drive inspection readiness, compliance, and operational excellence.
- Directly manage and develop Medical Data Reviewers,



establishing explicit expectations, accountability, and performance standards.
- Build team capability through hiring, coaching, training, and succession planning.
- Oversee Medical Data Review & Signal Detection ensuring high-quality review of adverse events, labs, vitals, ECGs, imaging, and key endpoints. Identify trends, outliers, protocol deviations, and emerging safety signals
- Serve as an escalation point for complex clinical data issues; providing expert clinical judgment to resolve complex or ambiguous data.
- Drive quality, compliance and risk management ensuring regulatory-ready documentation aligned with ICH-GCP, applying RBQM principles and leveraging KRIs/QTLs.
- Provide medical insight and strategic guidance to cross-functional partners to align data review outputs with study objectives and regulatory expectations.
- Strengthen and harmonize medical data review practices by advancing

📌 Senior Medical Data Reviewer (Hyderabad)
🏢 AMGEN
📍 Hyderabad