Medical Review Senior Associate Scientist – Pharmacovigilance (ICSR Medical Review)
Company: Amgen
Location: Hyderabad, India
Work Model: Onsite
Department: Global Patient Safety – PV Operations
Job ID: R-235713
Posted Date: 11 February 2026
Employment Type: Full-Time
About the Organization
Amgen is a global biotechnology leader dedicated to advancing innovative therapies for serious illnesses. The Global Patient Safety (GPS) function ensures robust pharmacovigilance systems, regulatory compliance, and patient safety monitoring across clinical development and post-marketing phases.
Role Overview
The Medical Review Senior Associate Scientist plays a critical role in Individual Case Safety Report (ICSR) medical review and pharmacovigilance compliance. The position supports global safety surveillance activities by ensuring medically accurate case assessments, regulatory reporting adherence, and inspection readiness.
This role is ideal for qualified physicians with prior drug safety or pharmacovigilance experience seeking to advance within global safety operations.
Key Responsibilities
ICSR Medical Review & Quality Assurance
Conduct comprehensive medical review of ICSRs, including narrative evaluation, coding validation, seriousness assessment, expectedness determination, and causality assessment.
Ensure medical validity and scientific accuracy of safety reports in compliance with global pharmacovigilance regulations.
Execute case escalations and appropriate follow-ups as per SOP requirements.
Serve as a medical point of contact for Case Management teams regarding ICSR content and clinical interpretation.
Regulatory Compliance & Safety Surveillance
Support global ICSR regulatory reporting compliance for investigational and marketed products.
Perform reportability assessments for medical device-related events and product complaint cases.
Contribute to systematic process improvements and medical coding conventions within PV operations.
Inspection Readiness & Governance
Support activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as outlined in the PV System Master File.
Maintain inspection readiness for Health Authority inspections and internal audits.
Represent the function during regulatory inspections within scope of responsibility.
Cross-Functional Collaboration
Participate in cross-functional initiatives including SOP development, standards enhancement, metrics reporting, and quality improvements.
Provide input into global safety processes and interdepartmental projects.
Educational Qualification (Basic Requirements)
MD/DO degree or international equivalent medical qualification.
Experience Required
Minimum:
1 year of relevant experience in drug safety, pharmacovigilance, or clinical safety review.
Preferred:
MD/DO or equivalent with 3+ years of experience in pharmacovigilance, ICSR medical review, or global safety operations.
Required Knowledge & Skills
Strong knowledge of pharmacovigilance regulations and ICSR reporting requirements (clinical trial and post-marketing settings).
Clinical understanding of therapeutic area patient populations and drug classes.
Proficiency with safety databases and medical coding systems (e.g., MedDRA).
Knowledge of drug development lifecycle and clinical trial processes.
Familiarity with global safety governance and regulatory frameworks.
Why Join Amgen Global Patient Safety?
Amgen fosters a culture of scientific excellence, ethical integrity, and patient-centric innovation. The Global Patient Safety team plays a pivotal role in safeguarding patients worldwide by ensuring high-quality medical safety review and regulatory compliance.
Advance your career in Pharmacovigilance, ICSR Medical Review, and Global Drug Safety Operations.
Explore more Medical Review, Drug Safety, and Clinical Development roles worldwide at ThePharmaDaily.com.
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