Senior Director of ICSR
Core
Manages the ICSR Management Unit, overseeing staff, resources, and processes to ensure high-quality pharmacovigilance case processing and patient safety reporting.
Role type
Senior Director, Pharmacovigilance Operations
Builds
Safe and effective pharmaceutical treatment outcomes through rigorous safety data processing and signal detection
Domain
Life Sciences / Pharmacovigilance / Regulatory Compliance
Deliverable
Production ML models | product features | dashboards & analysis | client delivery | infrastructure
Required skills
Post-marketing and clinical case processing, staff management, resource allocation, budget review, process improvement, CAPA review, operating procedure updates
Preferred skills
Medical device experience, business development, contract support, recruitment support
Technologies
MS Office (Advanced)
Responsibilities
Manage ICSR Management Unit and Associate Directors; Allocate resources and set productivity targets; Review budgets and project scopes; Approve Critical CAPAs; Update PrimeVigilance operating procedures; Mentor line managers and senior staff.
Seniority
Senior, hands-on IC with strategic oversight
