Sr Assoc Pharmacovigilance Operations
HyderabadFull-timeMid levelPosted over a month ago
Mid-level pharma role at Amgen in Hyderabad.
About the role
Support vendor oversight of all case intake and processing activities Manage queries on Intake, triage, and data entry of ICSRs Reporting decision for submitting all expedited safety reports to FDA/EMA Ensuring that individual ICSRs are evaluated for reporting in compliance with regulations and contracts
What you'll do
- Support vendor oversight of all case intake and processing activities
- Support convention-related training delivery
- Manage queries on Intake, triage, and data entry of ICSRs
- Reporting decision for submitting all expedited safety reports to FDA/EMA
- Ensuring that individual ICSRs are evaluated for reporting in compliance with regulations and contracts
What you need
- Pharmacovigilance