Company Name: Amgen India

Job Location: Hyderabad

Company URL: https://wwwext.amgen.com/

Work Mode: Hybrid (3days onsite, 2days WFH)

Job Link: https://amgen.wd1.myworkdayjobs.com/Careers/job/India---Hyderabad/Senior-Associate-Medical-Data-Reviewer_R-247300

Please find the job description below. If this opportunity interests you, you can apply using the link provided and confirm by replying to this email.

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, creative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

In this vital role, the Senior Associate - Medical Data Reviewer is responsible for ensuring the clinical integrity, quality, and interpretability of data generated across the clinical development lifecycle. The role applies strong medical and scientific judgment to complex clinical datasets to safeguard patient safety, enable timely signal detection, and support regulatory-ready decision making.

The position requires both clinical expertise and analytical rigor,



with the ability to distinguish clinically meaningful signals from background variability and drive appropriate actions when required.

- Conduct ongoing medical review of clinical trial data to ensure accuracy, consistency, and clinical relevance.
- Evaluate adverse events, laboratory data, vital signs, ECGs, imaging, and other key safety and efficacy endpoints.
- Identify trends, outliers, protocol deviations, and emerging safety signals across studies.
- Apply medical judgment to distinguish clinically meaningful findings from normal variability.
- Provide medical input into study start-up activities, including risk assessments and data review strategy.
- Partner cross-functionally with Clinical Operations, Data Management, Safety, Biostatistics, and vendors to resolve data issues.
- Contribute to the development and refinement of medical review tools, visualizations, and dashboards (e.g., Spotfire).
- Lead or contribute to data review meetings, governance discussions, and issue escalation processes.
- Author and maintain clear, defensible medical documentation to support inspection readiness.
- Drive continuous improvement by identifying systemic data quality trends and strengthening review standards and workflows.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Minimum Requirements:

- MBBS,



MD, PharmD, BDS, BAMS, BHMS, or other relevant medical/healthcare degree with clinical research experience
- Master’s degree in Life Sciences, Pharmacy, Public Health, or related field with 5+ years of clinical research experience
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related discipline with 7+ years of clinical research experience
- 5+ years of experience in clinical research within biotech, pharmaceutical, or CRO environments
- Experience reviewing large, complex clinical trial datasets
- Understanding of clinical data review processes and study conduct within GCP environments
- Experience with clinical data analysis or visualization tools (e.g., Spotfire, Power BI, or similar)
- Ability to interpret complex clinical datasets and translate findings into clear, actionable insights
- Strong written and verbal communication skills with experience presenting to cross-functional and leadership audiences

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

If you would like to discuss the opportunity further, feel free to reply to this email. I would be happy to connect and share more details.

📌 Senior Associate Medical Data Reviewer (Hyderabad)
🏢 Amgen
📍 Hyderabad