Associate Director Global Patient Safety
Core
Oversee global pharmacovigilance case operations, ensuring quality, timeliness, and compliance of Individual Case Safety Reports (ICSRs) across clinical and commercial programs.
Role type
Senior IC Associate Director, Pharmacovigilance Operations
Builds
Global drug safety operations and regulatory submission readiness
Domain
Pharmaceutical/Biotechnology, Pharmacovigilance
Required skills
Pharmacovigilance case management, ICSR processing and submission, Vendor management, Root cause analysis, Corrective and preventive actions (CAPA), Regulatory compliance (FDA, EU, ICH), Team leadership, Project management, KPI framework design, Audit and inspection readiness
Preferred skills
Advanced degree, Experience supervising complex cross-functional projects
Technologies
AI-enabled data ingestion tools, Case processing systems
Responsibilities
Oversee ICSR receipt, processing, distribution, and submission; Maintain ICSR quality standards and validity; Optimize AI-enabled data workflows; Support audits and health authority inspections; Lead root cause analysis and remediation; Manage CAPA closure and effectiveness checks; Establish KPI frameworks and conduct vendor governance; Mentor staff and communicate with management.
Seniority
Senior, hands-on IC with leadership responsibilities