Not specified; competitive total rewards plans ali...
Device/combination product icsr processing
Fda/ema regulatory compliance knowledge
Vendor oversight and quality management
The role is accountable for the global quality of device and combination product Individual Case Safety Reports (ICSR) processing for both clinical trial and post-market cases
Job Summary
The role is accountable for the global quality of device and combination product Individual Case Safety Reports (ICSR) processing for both clinical trial and post-market cases.
Candidates must ensure vendor compliance with approved processes while acting as the primary point of contact for FDA/EMA safety reporting submissions.
Amgen offers a collaborative culture focused on serving patients living with serious illnesses through innovative biotech research and manufacturing.
Matching Summary
The role is accountable for the global quality of device and combination product Individual Case Safety Reports (ICSR) processing for both clinical trial and post-market cases.
Salary
Not specified; Competitive Total Rewards Plans aligned with local industry standards; Base salary plus benefits included
Skills & Requirements
Must-have
Device/combination product ICSR processing
FDA/EMA regulatory compliance knowledge
Vendor oversight and quality management
Global pharmacovigilance regulatory requirements
Audit and inspection support experience
Nice-to-have
Experience with corporate intake systems
Familiarity with safety database tools
Project management tool proficiency
Collaborative team environment experience
High case level productivity focus
Key Requirements
Doctorate degree plus 4 years Drug Safety experience OR Master's plus 7 years OR Bachelor's plus 9 years
Pharmacovigilance or Quality experience in biotech/pharma/device industry preferred
Bachelor's Degree in healthcare subject area or scientific field preferred
Understanding of Good Manufacturing Practices and Good Pharmacovigilance Practices