(Senior) Director, Drug Safety and Pharmacovigilance Operations
Core
Spearhead the evolution of the drug safety framework for Phase 3 clinical programs, balancing strategic oversight of external partners with hands-on systems building to ensure regulatory compliance and successful filings.
Role type
Senior Director, Pharmacovigilance Operations
Builds
Global PV systems, processes, and safety governance frameworks
Domain
Biotechnology / Clinical Drug Development / Pharmacovigilance
Required skills
Global safety strategy, PV operations, regulatory engagement, safety data review, aggregate analyses, safety signal detection, global PV regulations knowledge, inspection readiness management, risk management planning
Preferred skills
Building or scaling a pharmacovigilance function, experience in monoclonal antibody space
Technologies
ARGUS, ARISg, Veeva Vault Safety
Responsibilities
Manage PV vendors and agreements; Provide expert oversight for safety data review and periodic/individual safety reports; Facilitate safety signal detection and management; Oversee global PV systems and processes; Lead inspection readiness and audit responses; Develop and maintain SOPs and safety governance frameworks; Drive development of risk management plans and benefit-risk assessments
Seniority
Senior Director, strategic oversight & execution