Senior Director, Global PV Operations & Safety Science
Company Name
ADC Therapeutics
Job Overview
The Senior Director, Global PV Operations & Safety Science is responsible for developing and implementing the strategy for pharmacovigilance (PV) operations and driving operational excellence. This role oversees the execution of key safety processes to ensure regulatory compliance and supports scientific analysis.
Responsibilities
- Managing PV vendors for ICSR management and regulatory reporting
- Ensuring compliance with global authorities
- Implementing the PV QMS
- Leading safety agreement development
- Supporting signal and risk management activities
- Contributing to aggregate safety reports and regulatory submissions
Requirements
- 10+ years of PV operations experience
- Expert knowledge of global PV regulations