Case Management – Specialist (Device Safety)
Amgen(1 year ago)
About this role
The role is responsible for ensuring the global quality and compliance of device/combination product Individual Case Safety Reports (ICSRs) across clinical trial and post-market settings. The position oversees vendor performance and training, serves as a local safety office and regulatory reporting contact, and provides audit and inspection support. It supports activities delegated by the Qualified Person for Pharmacovigilance and helps maintain inspection readiness.
Required Skills
- Pharmacovigilance
- Case Processing
- Vendor Oversight
- Regulatory Reporting
- Audit Support
- Quality Management
- Clinical Development
- Project Management
- Microsoft Office
- Analytical Skills
Qualifications
- Doctorate Degree
- Master's Degree
- Bachelor's Degree
About Amgen
amgen.comAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
View more jobs at Amgen →Apply instantly with AI
Let ApplyBlast auto-apply to jobs like this for you. Save hours on applications and land your dream job faster.
More jobs at Amgen
Similar Jobs
Director - Case Management Medical Review
LI Test Company(2 months ago)
Japan Local Case Advisor, GBS Patient Safety
American Association of Physicists in Medicine(2 months ago)
Japan Local Case Advisor, GBS Patient Safety
American Association of Physicists in Medicine(1 month ago)
Sr. Manager, ICSR Quality
CSL Innovation(2 months ago)
Japan Local Case Advisor, GBS Patient Safety
American Association of Physicists in Medicine(1 month ago)
Director, Medical Evaluation & Case Processing Oversight
CSL Innovation(1 month ago)