Posted 3 months ago
Senior Associate Medical Data Reviewer
HyderabadOn-siteFull-time
AI Summary
Reviews clinical trial data to ensure integrity and patient safety, applying medical judgment to detect signals, interpret complex datasets, and support regulatory decisions.
About this role
Career Category
ClinicalJob Description
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
OR
Master’s degree in Life Sciences, Pharmacy, Public Health, or related field with 5+ years of clinical research experience
OR
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
Skills
Adverse Event EvaluationClinical Data ReviewClinical Trial Data AnalysisData VisualizationECG InterpretationGCPLaboratory Data ReviewMedical DocumentationPower BIProtocol Deviation ReviewSignal DetectionSpotfire
Explore related jobs
More jobs at Amgen Inc.
- Undergrad Co-op - Quality, Manufacturing, Operations and/or EngineeringUS - Puerto Rico - Juncos
- Account Manager / Specialty Account Manager - TEPEZZA (Rare Disease) - Greensboro, NCUS - North Carolina - Charlotte
- Manufacturing Process Technician- 12 hour shift 6pm-6amUS - Ohio - New Albany
- Senior Scientist - PKDM-BAUS - California - South San Francisco
- Sr Associate Software EngineerIndia - Hyderabad
- Associate — Incentive Compensation AdministrationIndia - Hyderabad
Similar Adverse Event Evaluation jobs
Jobs in Hyderabad
- Job Posting Title Senior Software Engineer - Liquidity Book- Java FullstackFactSet Hong Kong Limited · Hyderabad, IND
- Enterprise Recruitment RepresentativeApplyBoard India Private Limited · Hyderabad
- Senior Software Engineer - Liquidity Book- Java FullstackFactSet Hong Kong Limited · Hyderabad, IND
- Senior Data Recoverability Engineer (Data Governance)FactSet Hong Kong Limited · India, Hyderabad
- Associate scientistLaboratorio de Control ARJ, S. A. de C. V. · Hyderabad, India
Senior Data ScientistDazn · India - Hyderabad
Browse these categories
Market data for this role
All reports →- SeriesRole reportsOne role family at a time: how many openings, what changed this week, who is hiring, what it pays.
- SeriesSalary reportsWhat employers publish in job postings, by level and workplace. Not self-reported pay.
- Market overviewState of tech hiring, September 2026: up 4.8%Tech hiring rose 4.8% month over month in September 2026, with 411,122 new listings. Customer support and account executive roles led the growth.