Senior Manager (Safety Ops/Safety Scientist)
Core
Lead global patient safety case management, oversee drug safety vendor operations, and ensure regulatory compliance for pharmacovigilance activities.
Role type
Senior Manager, Pharmacovigilance Operations
Builds
Global patient safety case management systems and vendor oversight programs
Domain
Biotechnology / Oncology / Pharmacovigilance
Required skills
Global ICSR regulations, Pharmacovigilance operations, Vendor management, Regulatory submission compliance, Inspection readiness, Data reconciliation, Metrics analysis, SOP development
Preferred skills
Biotechnology/pharmaceutical sector knowledge, Cross-functional collaboration, Team leadership, Project planning
Technologies
ICSR systems, Safety databases, Aggregate reporting tools
Responsibilities
Lead global ICSR activities to comply with regulations; Manage PV programs from study start-up to closure; Oversee external case management vendors and CAPA development; Ensure submission compliance with regulatory authorities; Support inspection readiness; Reconcile safety and clinical databases for Serious Adverse Events; Develop Standard Operating Procedures for PV and Safety.