- Princeton, New Jersey, United States
- Full-time · Manager
- 3+ years
The role is responsible for supporting the Senior Director of Pharmacovigilance (PV) Operations with elements of the pharmacovigilance function. This includes overall accountability for vendor management/oversight; training; business integration; Quality Management System (QMS); Safety Data Exchange Agreements (SDEAs); PV Safety database, and CAPA management.
Responsibilities
- Coordinate the daily management and execution of drug safety (DS) and pharmacovigilance (PV) operations.
- Work with compliance with regulations, PV agreements, and internal SOPs.
- Represent the Drug Safety and Pharmacovigilance departments on clinical development teams.
- Oversee SAE (Serious Adverse Event) processing by outsourced vendors, and review and monitor compliance operations.
- Execute strategies to achieve and maintain the desired level of quality including, by analyzing and mitigating compliance risk.
Requirements
- Bachelor’s degree in healthcare
- BSN
- RN degree
- RPh
- PharmD