Senior Manager, Safety Cluster Lead
Core
Lead local Pharmacovigilance (PV) operational activities across multiple territories, ensuring regulatory compliance and patient safety.
Role type
Senior Manager, Safety Cluster Lead (Pharmacovigilance Operations)
Builds
Local PV operational delivery, vendor-managed safety reporting, and audit-ready compliance frameworks.
Domain
Life Sciences / Pharmacovigilance / Regulatory Affairs
Required skills
Pharmacovigilance operations leadership, vendor management, regulatory compliance (GVP), audit/inspection readiness, safety case processing, project management
Preferred skills
Specialization in Drug Safety or Regulatory Affairs, experience in multinational PV environments
Technologies
GVP Module VI, Safety Management Plans, ICSR management systems
Responsibilities
Provide leadership and oversight for local PV activities; manage PV intake vendors and monitor performance; act as primary contact for audits and regulatory inspections; collaborate with Global Safety and Clinical Safety teams; drive process improvement and operational excellence.
Seniority
Senior Manager, operational leadership