Case Management - Specialist (Device Safety)

Roles & Responsibilities
• Ensure high-quality processing of Individual Case Safety Reports (ICSRs) for device and combination products
• Oversee vendors for case intake, processing quality, and performance metrics
• Submit safety reports to FDA, EMA, and other global regulatory authorities
• Act as US/EU local safety office contact point for device safety matters
• Manage safety reporting timelines for clinical trial and post-market cases
• Support PASR (Periodic Aggregate Safety Reports) activities
• Ensure compliance with global GVP, GMP, and internal SOP requirements
• Support audit and inspection readiness under QPPV delegation
• Maintain documentation and compliance within the Quality Management System (QMS)

Qualification
• Doctorate + 4 years of Drug Safety/Life Sciences experience OR
• Master’s degree + 7 years of Drug Safety/Life Sciences experience OR
• Bachelor’s degree + 9 years of Drug Safety/Life Sciences experience

Experience
• Strong experience in Pharmacovigilance, Drug Safety, or Device Safety
• Experience in ICSR processing for device or combination products
• Exposure to regulatory submissions (FDA, EMA)
• Vendor management and compliance oversight experience preferred

Skills
• In-depth knowledge of global pharmacovigilance regulations
• Strong understanding of device and combination product safety reporting
• Experience with safety databases and intake systems
• Attention to detail and regulatory accuracy
• Proficiency in MS Office (Excel, Word, PowerPoint, Outlook)
• Ability to work effectively in a global matrix environment
• Strong analytical and problem-solving skills

About the Organization
Amgen is a global biotechnology leader focused on innovative therapies for serious illnesses, operating with strong regulatory compliance, scientific excellence, and patient-centric safety standards across global markets.