Associate Director Global Patient Safety
Core
Lead vendor oversight and ICSR quality governance for global pharmacovigilance case processing across development and commercial programs.
Role type
Associate Director, Pharmacovigilance Operations
Builds
End-to-end Individual Case Safety Report (ICSR) receipt, processing, distribution, and submission for global development and marketed products.
Domain
Life Sciences / Pharmacovigilance / Drug Safety
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Vendor management, ICSR quality standards, regulatory compliance (FDA/EU/ICH), root cause analysis, CAPA management, team leadership, project management, AI tool evaluation
Preferred skills
Advanced degree in Pharmacy or Nursing
Technologies
AI-enabled data ingestion tools, workflow automation platforms
Responsibilities
Own accurate, timely case processing per regulations and SOPs; Lead vendor oversight for ICSR lifecycle; Establish tiered quality review frameworks; Monitor submission timelines and vendor SLAs; Lead root cause analysis and CAPA closure; Evaluate AI-enabled tools for workflow automation
Seniority
Senior, hands-on IC with team leadership
