Sr. Manager- Pharmacovigilance Operations
Salary: 160,000
Remote
A rapidly growing midsize bio-pharmaceutical company is looking for a Sr. Pharmacovigilance Operations Manager to provide leadership to the pharmacovigilance team regarding the management of case processes, vendors, periodic safety reports, and safety databases. This position will support risk management and PV activities on both clinical trials and post marketed products.
Responsibilities:
- Vendor oversight and management.
- Coordinate and review ICSR activities and review AE's
- Track and report KPI's
- Author and review SMP's, safety data exchange agreements, and SOP's.
- Assist with the preparation of DSUR's, CSRs, RMP, and IBs.
- Manage CAPA activities.
- Oversee quality control of SAE and ICSR cases in safety databases.
Requirements:
- Bachelors/Advanced degree in life science or other healthcare related professions (MD, RN, PharmD, PhD, etc.)
- 6-8 years in the PV space.
- Experience in PV activities on both pre- and post-approved products.
- Experience in using ARGUS.
- Working understanding of MedDRA and WHO
