Medical Review Senior Associate Scientist

Roles & Responsibilities
• Perform medical review of ICSRs including narratives, coding, expectedness, causality, and seriousness assessment
• Ensure medical validity and produce accurate, high-quality ICSR reports
• Conduct case escalation and follow-up activities as per SOPs
• Assess reportability for medical device and product complaint-related events
• Act as medical point of contact for Case Management teams
• Support medical coding standards and continuous process improvements
• Contribute to SOP development, metrics tracking, and cross-functional initiatives
• Maintain inspection readiness and support Health Authority inspections and internal audits
• Undertake delegated QPPV activities as per PV System Master File

Qualification
• MD / DO or international equivalent (Mandatory)

Experience
• Minimum 1 year of related drug safety experience (Basic requirement)
• 3+ years of relevant pharmacovigilance experience preferred

Skills
• Strong knowledge of pharmacovigilance regulations and ICSR medical review
• Understanding of clinical trials and post-marketing safety
• Proficiency in safety databases and medical coding systems
• Clinical knowledge of therapeutic areas and drug classes
• Strong analytical, documentation, and compliance skills

About the Organization
Amgen is a global biotechnology company committed to discovering and developing innovative therapies. Through its Global Patient Safety team, the organization ensures high pharmacovigilance standards to protect patients worldwide.