Position Overview
Our Client, a Pharmaceutical company, is looking for a Senior Director Drug Safety and Pharmacovigilance for their Princeton, NJ location. Responsibilities:
+ Medical review of Individual Case Safety Reports (ICSRs) for assigned product(s) to ensure accuracy, integrity and completeness of safety information including providing company causality as required.
+ Accountable for medical evaluation/interpretation of aggregate safety data of assigned product(s) including signal detection and evaluation, and ad hoc safety assessments.
+ Work in close collaboration with cross-functional teams and counterparts in regulatory labeling, clinical development, pre-clinical, manufacturing/quality, and other functional areas to identify, evaluate, and communicate safety issues, as assigned.
+ Provide support for the safety aspects for clinical studies, and development and maintenance of the company core safety information.
+ Provide support fo...