Senior Associate Medical Data Reviewer

Amgen Inc. (IR); Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Amgen Inc. is seeking a Senior Associate - Medical Data Reviewer in Hyderabad to ensure the clinical data's integrity and interpretability across the development lifecycle.

You will apply clinical judgment to complex datasets, safeguard patient safety, and enable timely signal detection for regulatory-ready decisions. You will review adverse events, labs, vital signs, ECGs, imaging, and other endpoints, identify trends and protocol deviations, and collaborate with operations, data management,

Qualifications

• MBBS/MD/PharmD/BDS/BAMS/BHMS 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 in Life Sciences, Pharmacy, Nursing or related discipline with 7+ years of clinical research experience
• Experience reviewing large, complex clinical trial datasets
• Understanding of clinical data review processes and GCP environments

Responsibilities

• Conduct ongoing medical review of clinical trial data to ensure accuracy, consistency, and clinical relevance
• Evaluate adverse events, lab data, vital signs, ECGs, imaging and other safety endpoints
• Identify trends, outliers, protocol deviations, and emerging safety signals
• 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
• Contribute to medical review tools, visualizations and dashboards (Spotfire/Power BI)
• Lead or contribute to data review meetings and issue escalation processes
• Author and maintain defensible medical documentation for inspection readiness
• Drive continuous quality improvement of data review standards and workflows

Skills

Strong communication skills

Clinical data interpretation

Data quality vigilance

Collaboration with cross-functional

Education

MBBS/MD/PharmD/BDS/BAMS/BHMS with clinical research

Master's in Life Sciences/Pharmacy/Public Health +5 years CRA

Bachelor's in Life Sciences/Pharmacy/Nursing +7 years CRA

Tools

Spotfire

Power BI

Job description

Senior Associate - Medical Data Reviewer

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.

Basic Qualifications

• 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

Preferred Qualifications

• 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.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen