Associate Director, PV Case Operations
Core
Provide oversight of pharmacovigilance (PV) operations, managing vendor and case processing deliverables, ensuring inspection readiness, and governing ICSR quality standards and CAPA ownership.
Role type
Senior IC Associate Director, Pharmacovigilance Operations
Builds
Global PV case processing workflows, quality review frameworks, and vendor performance metrics for marketed products and development programs.
Domain
Life Sciences / Pharmacovigilance / Drug Safety
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmacovigilance/Drug Safety operations, ICSR quality review, CAPA management, root cause analysis, vendor management, regulatory compliance (FDA/EU/ICH), team mentorship, operational metrics tracking
Preferred skills
Advanced Degree, experience managing complex cross-functional projects
Technologies
None explicitly stated
Responsibilities
Oversee ICSR quality review processes and establish tiered quality review frameworks; Drive continuous improvement by identifying trends and implementing remediation; Lead root cause analysis for quality deviations and compliance failures; Develop and track Corrective and Preventive Actions (CAPAs) to closure; Manage vendor performance metrics and conduct governance meetings; Ensure compliance with regulations and SOPs; Mentor assigned staff and communicate deliverables to senior management.
Seniority
Senior, hands-on IC with management oversight
