Sr Assoc Pharmacovigilance Operations

Role & Responsibilities
• Act as US/EU local safety office and FDA/EMA point of contact
• Submit ICSRs to FDA, EMA, and business partners
• Perform case review, quality checks, and escalation of safety issues
• Ensure timely expedited safety reporting
• Support vendor oversight for case intake, triage, processing, and quality metrics
• Conduct clinical trial and business partner reconciliations
• Manage ICSR intake, triage, data entry queries, and E2B support
• Support audit readiness, health authority inspections, and internal audits
• Assist in PV training delivery and delegated QPPV activities

Qualifications & Experience
• Bachelor’s degree with 2+ years of pharmacovigilance experience, or
• Associate degree with 6+ years of relevant experience, or
• High school diploma/GED with 8+ years of pharmacovigilance experience

Skills
• Strong knowledge of global pharmacovigilance regulations
• Experience in ICSR case processing and reporting
• Proficiency in safety databases and MS Office tools
• High attention to detail and compliance orientation

About the Company
• Amgen is a global biopharmaceutical leader delivering innovative therapies and maintaining world-class pharmacovigilance operations