Pharmacovigilance Licensing Manager
Core
Own the end-to-end lifecycle of Pharmacovigilance Agreements (PVAs) and manage strategic collaborations to ensure compliant pharmacovigilance obligations for rare disease products.
Role type
Senior Pharmacovigilance Agreements Manager
Builds
Strategic alliances and partnerships for patient safety and regulatory compliance
Domain
Biopharmaceuticals / Rare Diseases / Pharmacovigilance
Deliverable
client delivery
Required skills
End-to-end agreement lifecycle management, global pharmacovigilance regulations expertise, negotiation, cross-functional collaboration, audit and inspection support, process improvement, CAPA planning
Preferred skills
Life Sciences degree, experience in safety alliances or partnership management, knowledge of additional languages
Technologies
None stated
Responsibilities
Lead negotiation and establishment of pharmacovigilance agreements, oversee external business partner collaborations, support pharmacovigilance audits and inspections, train internal teams on PV standards, identify process improvement opportunities
Seniority
Senior, hands-on IC