Associate Director, Global Patient Safety (GPS) Individual Case Safety Report (ICSR) Therapeutic Area (TA) Lead
Core
Oversees global Individual Case Safety Report (ICSR) processing excellence and external business management for a specific therapeutic area, ensuring adherence to pharmacovigilance regulations and managing vendor partners.
Role type
Senior IC pharmacovigilance operations lead (ICSR)
Builds
Global ICSR processing workflows and vendor management programs
Domain
Life sciences / Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ICSR processing and reporting, external partner and vendor management, pharmacovigilance regulations, project management, line management, audit and inspection response, cross-functional collaboration
Preferred skills
automation and AI implementation, process harmonization, mentoring
Technologies
None explicitly stated
Responsibilities
Lead TA ICSR operations, manage external PV partners and vendors, serve as subject matter expert for audits and health authority inquiries, mentor staff on PV aspects, contribute to best practices including automation, collaborate on quality improvements
Seniority
Senior, hands-on IC with management responsibilities
