Senior Manager PV Sweden & Affiliate Safety Representative

About the role

Viatris, a global healthcare company, is hiring a Senior Manager PV Sweden and Affiliate Safety Representative in Solna. The role is responsible for running a compliant pharmacovigilance (PV) system for Viatris in Sweden, supervising the PV team and acting as the main contact for Swedish health authorities on PV matters.

Key responsibilities

• Organize, manage and maintain a highly compliant PV system for Viatris in Sweden.
• Ensure adherence to local and global PV processes, guidelines and national and international regulations.
• Lead, supervise and coordinate the PV team and PV-related external service providers in Sweden.
• Ensure PV business continuity and act as main contact for Swedish Health Authorities regarding PV and inspections.
• Lead and coordinate internal and external PV audits and inspections.
• Monitor affiliate PV system performance and compliance, and plan and manage the local PV budget.
• Handle individual case safety reports, cooperate on PSUR submissions, archive records, implement local risk minimization measures and fulfill PV agreements.
• Maintain updated local SOPs aligned with global processes, train affiliate employees and service providers, and cooperate with global PV teams.

Required profile

• Medical, pharmacy or life sciences degree (or equivalent).
• At least three years of experience in the pharmaceutical industry and two years in pharmacovigilance.
• Management and leadership skills with a high level of autonomy.
• Excellent written and spoken English and Swedish.
• Deep knowledge of European and Swedish PV regulations; knowledge of cosmetovigilance, medical device vigilance and food supplement vigilance is strongly recommended.

Required skills

• Good knowledge of international PV regulations such as ICH and CIOMS is strongly recommended.
• Technical writing, including SOPs, corrective action plans and exception reports.
• Strong organizational, facilitation and interpersonal skills in cross-functional teams, including virtual collaboration.