Medical Review Senior Associate Scientist
Company: Amgen
Location: Hyderabad, India
Department: Global Patient Safety – Pharmacovigilance Operations
Job ID: R-235713
Work Mode: Onsite
Job Type: Full-Time
Experience Required:
Minimum 1+ year of pharmacovigilance or drug safety experience with an MD/DO or international equivalent degree
3+ years of relevant pharmacovigilance experience preferred
Education: MD / DO or International Equivalent Medical Degree
About Amgen
Amgen is a global biotechnology company focused on developing innovative therapies that address serious diseases. Through advanced scientific research and a strong commitment to patient safety, Amgen continues to improve treatment outcomes across multiple therapeutic areas. The Global Patient Safety organization ensures that safety data for Amgen products is monitored, analyzed, and reported according to international pharmacovigilance regulations.
Job Overview
Amgen is seeking a Medical Review Senior Associate Scientist to support pharmacovigilance and drug safety activities within the Global Patient Safety team. The role involves reviewing Individual Case Safety Reports (ICSRs) to ensure medical accuracy, regulatory compliance, and high-quality safety documentation.
The specialist will contribute to safety surveillance activities by evaluating adverse event reports, ensuring appropriate medical coding, assessing causality and seriousness, and supporting regulatory reporting requirements. The role also involves collaboration with case management teams and participation in pharmacovigilance process improvements.
Key Responsibilities
Medical Review of Safety Reports
Perform detailed medical review of Individual Case Safety Reports (ICSRs) including narratives, coding accuracy, expectedness assessment, seriousness classification, and causality evaluation.
Ensure the medical validity and completeness of safety reports before submission to regulatory authorities.
Generate medically accurate safety narratives aligned with pharmacovigilance standards.
Safety Case Management Support
Act as a key point of contact for case management teams regarding medical content and clinical evaluation of safety cases.
Conduct case escalation when required according to established pharmacovigilance procedures.
Execute follow-up activities for safety cases as per standard operating procedures.
Pharmacovigilance Compliance and Reporting
Ensure ICSRs meet global pharmacovigilance regulatory requirements and reporting timelines.
Perform reportability assessment for medical device-related adverse events and product complaint cases.
Evaluate safety data from both clinical trial settings and post-marketing surveillance activities.
Quality Assurance and Process Improvement
Support quality assurance processes related to ICSR medical review activities.
Contribute to cross-functional initiatives including process improvement, SOP development, and safety review standards.
Assist in implementing improvements in medical coding conventions and safety review workflows.
Regulatory Inspection Readiness
Participate in activities supporting pharmacovigilance inspection readiness as outlined in the PV System Master File.
Act as a representative during regulatory health authority inspections and internal audits when required.
Ensure compliance with pharmacovigilance governance standards and documentation requirements.
Required Skills and Competencies
Strong understanding of pharmacovigilance regulations and drug safety reporting standards.
Experience reviewing Individual Case Safety Reports and safety narratives.
Knowledge of medical coding systems and safety databases used in pharmacovigilance operations.
Understanding of clinical trials, drug development processes, and post-marketing safety surveillance.
Ability to evaluate clinical data and assess adverse event causality and seriousness.
Strong analytical, documentation, and communication skills.
Preferred Qualifications
3+ years of experience in pharmacovigilance or drug safety operations.
Familiarity with global safety reporting standards and regulatory frameworks.
Knowledge of Amgen products and therapeutic area patient populations.
Experience participating in safety review process improvements or regulatory inspection preparation.
Why Join Amgen
Amgen provides a dynamic scientific environment where healthcare professionals contribute to global patient safety and drug development programs. Employees gain exposure to advanced pharmacovigilance systems, cross-functional collaboration, and opportunities to support life-saving therapies while maintaining the highest safety and regulatory standards.
Job Location
Hyderabad, India (Onsite Role)
Department
Global Patient Safety – PV Operations
Category
Safety / Pharmacovigilance
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