Manager, Drug Safety - ICSR Processes
Core
Define, design, maintain, and improve global Individual Case Safety Report (ICSR) process standards, conventions, and procedural documentation for clinical and post-marketing safety activities.
Role type
Manager, Drug Safety (Process & Compliance)
Builds
Global ICSR process standards, procedural documentation, and system requirements for safety operations
Domain
Pharmaceutical / Pharmacovigilance / Regulatory Compliance
Required skills
ICSR processing, global safety regulations, process management, SOP authoring, regulatory interpretation, system requirements translation
Preferred skills
Safety system enhancements, UAT, inspection readiness, audit support, cross-functional global project leadership
Technologies
Pharmacovigilance systems
Responsibilities
Define and maintain business requirements for ICSR intake and case processing; Conduct impact assessments and User Acceptance Testing (UAT) for safety system enhancements; Lead process change management, communications, and training; Support SOPs, job aids, training content, inspection readiness activities, audits, and health authority interactions
Seniority
Manager, hands-on leadership