Director, Patient Safety ICSR
Core
Oversees global Individual Case Safety Report (ICSR) processing, external PV partners, and vendors for drug-device combination products, ensuring compliance and inspection readiness.
Role type
Director, Pharmacovigilance (PV) Operations
Builds
Global safety operations and vendor management for drug-device combination products
Domain
Biotechnology / Pharmacovigilance / Regulatory Compliance
Deliverable
client delivery
Required skills
ICSR processing, vendor management, project management, team leadership, regulatory compliance, quality control, stakeholder engagement
Preferred skills
Line management, cross-functional collaboration, procedural gap analysis
Technologies
Global Safety Database
Responsibilities
Lead and mentor staff in pre- and post-market PV; manage business partners and vendors; establish and oversee processes for adverse event reporting; contribute to Global Safety Database configurations; develop standardized practices and KPIs; provide technical guidance on case processing.
Seniority
Director, strategic leadership & hands-on management
