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Senior Associate Medical Data Reviewer

Amgen
5+ years
INR 12 LPA – 20 LPA
Hyderabad
1 June 18, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: CPT, HCPCS Level II, ICD-10-CM, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICD-10-PCS, Medical Billing, Medical Coding

Senior Associate – Medical Data Reviewer

Location: Hyderabad, India
Employment Type: Full-Time
Work Mode: On-Site

Role Summary

The Senior Associate – Medical Data Reviewer is responsible for ensuring the clinical integrity, quality, and interpretability of data generated throughout the clinical development lifecycle. The role requires strong medical and scientific expertise to evaluate complex clinical datasets, identify meaningful safety signals, support patient safety, and contribute to regulatory-ready decision-making.

This position combines clinical knowledge with analytical skills to assess clinical data, distinguish clinically relevant findings from background variability, and drive appropriate actions when necessary.


Key Responsibilities

Clinical Data Review & Medical Assessment

  • Conduct ongoing medical review of clinical trial data to ensure accuracy, consistency, and clinical relevance.

  • Review and evaluate:

    • Adverse Events (AEs)

    • Laboratory Data

    • Vital Signs

    • ECG Data

    • Imaging Results

    • Safety and Efficacy Endpoints

  • Apply medical judgment to identify clinically meaningful findings and differentiate them from normal variability.

  • Detect trends, outliers, protocol deviations, and emerging safety signals across studies.

Safety Surveillance & Signal Detection

  • Support proactive identification and evaluation of safety signals.

  • Contribute to patient safety monitoring through ongoing review of clinical data.

  • Escalate significant findings and safety concerns through appropriate governance channels.

Study Planning & Risk Assessment

  • Provide medical input during study start-up activities.

  • Participate in risk assessments and development of data review strategies.

  • Support the establishment of effective clinical data review processes.

Cross-Functional Collaboration

  • Collaborate with:

    • Clinical Operations

    • Data Management

    • Pharmacovigilance/Safety Teams

    • Biostatistics

    • External Vendors

  • Work closely with stakeholders to investigate and resolve data quality issues.

  • Participate in cross-functional discussions related to study conduct and data integrity.

Data Analytics & Visualization

  • Contribute to the development and enhancement of medical review tools, dashboards, and visualizations.

  • Utilize clinical data analysis platforms such as:

    • Spotfire

    • Power BI

    • Similar visualization and analytics tools

  • Support data-driven decision-making through effective interpretation and presentation of findings.

Governance & Documentation

  • Lead or participate in:

    • Data Review Meetings

    • Governance Discussions

    • Issue Escalation Processes

  • Maintain clear, accurate, and inspection-ready medical documentation.

  • Ensure findings and decisions are appropriately documented for regulatory compliance.

Continuous Improvement

  • Identify recurring data quality trends and process gaps.

  • Support continuous improvement initiatives to strengthen review standards and workflows.

  • Contribute to optimization of medical data review processes and best practices.


Required Qualifications

Education

One of the following qualifications:

  • MBBS

  • MD

  • PharmD

  • BDS

  • BAMS

  • BHMS

  • Other Relevant Medical/Healthcare Degree with Clinical Research Experience

OR

  • Master's Degree in:

    • Life Sciences

    • Pharmacy

    • Public Health

    • Related Disciplines

    • With 5+ years of Clinical Research Experience

OR

  • Bachelor's Degree in:

    • Life Sciences

    • Pharmacy

    • Nursing

    • Related Disciplines

    • With 7+ years of Clinical Research Experience


Preferred Experience

  • 5+ years of experience in Clinical Research within:

    • Pharmaceutical Companies

    • Biotechnology Organizations

    • CROs

  • Experience reviewing large and complex clinical trial datasets.

  • Strong understanding of:

    • Clinical Data Review Processes

    • Clinical Trial Conduct

    • Good Clinical Practice (GCP)

  • Experience with data analytics and visualization tools such as Spotfire, Power BI, or equivalent platforms.

  • Experience presenting findings to cross-functional teams and leadership stakeholders.