Drug Safety and Post Marketing Surveillance Manager
Core
Lead the safety and post-market oversight of McKesson's private label pharmaceutical products, ensuring compliance and patient safety.
Role type
Senior IC drug safety and pharmacovigilance manager
Builds
Post-market surveillance program, safety reports, and recall processes for private label pharmaceuticals
Domain
Pharmaceuticals (Private Label/Generics) + Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmacovigilance, Adverse event assessment, Safety signal evaluation, Regulatory submissions, Quality Management Systems (QMS), CAPA management, FDA regulations, ICH guidelines, Technical writing, Project management
Preferred skills
Generics/private label market experience, MasterControl, Argus, AI tools in drug safety
Technologies
MasterControl, Argus
Responsibilities
Lead and coach a team of drug safety specialists; Evaluate product complaints, adverse events, and medical queries for safety risks; Prepare and submit safety reports to the FDA; Lead private label product recall processes; Manage supplier safety data exchange agreements and third-party service providers; Support new product launches with risk-based compliance guidance
Seniority
Senior, hands-on IC with leadership
