Senior Specialist, Drug Safety

Job Description

The Position

The PV Senior Specialist collaborates with colleagues to ensure compliance with local laws and regulations, including backing up colleagues and adjusting schedules such that there is no gap in adverse event reporting and safety oversight. The Sr. Specialist may serve as the deputy/back-up Qualified Person for PV (QPPV) / Local Responsible PV person as required per local PV legislation. In the absence of their manager, he/she is responsible for managing all day-to-day activities of the PV and RA department and serves as their back-up.

Responsibilities

The PV Senior Specialist is responsible for all PV activities and may serve as the PV contact with local stakeholders, headquarters (HQ) and the local health authority.

The Sr. Specialist is also responsible for PV activities (as delegated/assigned by their Manager) which may include but...