Case Management – Specialist (Device Safety)
AmgenHyderabad, Telangana, India
Posted February 2, 2025
Full Time
About the Company
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
Job Description
Join Amgen's mission to serve patients with serious illnesses by supporting interactions with business partners and vendors for case intake and processing activities. Ensure quality of device/combination product Individual Case Safety Reports (ICSR) processing globally for clinical trial and post-market cases.
Requirements
- Support interactions with business partners and vendors for all case intake and processing activities
- Ensure vendor compliance with approved processes and training requirements
- Submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors
- Act as US/EU local safety office and FDA/EMA point of contact for safety reporting
- Provide audit & external inspection support
- Responsible for raising device/combination product case related issues
Benefits
- Competitive base salary
- Comprehensive Total Rewards Plans
- Equal Opportunity employer