(Senior) Director, Drug Safety and Pharmacovigilance Operations
Core
Spearhead the evolution of the drug safety framework for Phase 3 clinical programs, ensuring regulatory compliance and paving the way for successful filings and commercial launch.
Role type
Senior Director, Drug Safety and Pharmacovigilance Operations
Builds
Global PV systems, processes, and safety governance frameworks
Domain
Biotechnology / Oncology / Immunology / Women's Health
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global safety strategy, PV operations, regulatory engagement, safety database management, global regulatory PV submissions, health authority interactions, global PV regulations knowledge, risk management planning, benefit-risk assessment
Preferred skills
Building or scaling a pharmacovigilance function, monoclonal antibody space experience
Technologies
ARGUS, ARISg, Veeva Vault Safety
Responsibilities
Manage PV vendors, agreements, and Safety Management Plans; Provide expert oversight for safety data review and periodic/individual safety reports; Facilitate safety signal detection, validation, and management; Oversee global PV systems and processes for case processing and aggregate reporting; Lead inspection readiness and manage responses to audits and regulatory inquiries; Develop and maintain SOPs and safety governance frameworks; Drive development of risk management plans and benefit-risk assessments
Seniority
Senior Director, strategic oversight & hands-on systems building
