Senior Manager PV Sweden & Affiliate Safety Representative
Core
Organize, manage, and maintain a highly compliant Pharmacovigilance (PV) system for Viatris in Sweden, acting as the main contact for health authorities and leading the local PV team.
Role type
Senior Manager, Pharmacovigilance
Builds
Compliant PV systems and regulatory submissions for the Swedish market
Domain
Healthcare / Pharmaceutical Industry / Pharmacovigilance
Deliverable
client delivery
Required skills
Medical, Pharmacy, or Life-sciences degree; Management and leadership; Deep knowledge of European and Swedish pharmacovigilance regulations; Technical writing and authoring (SOPs, exception reports); Analytical skills with attention to detail
Preferred skills
Knowledge of cosmetovigilance, medical device vigilance, and food supplements vigilance; Knowledge of international PV regulations (ICH, CIOMS)
Technologies
None stated
Responsibilities
Organize and maintain the local PV system; Lead and coordinate the PV team and external service providers; Act as main contact for Swedish Health Authorities; Plan and manage the local PV budget; Manage Individual case safety reports and PSUR submissions; Maintain updated local SOPs
Seniority
Senior, hands-on IC with management responsibilities
