PV Specialist (Drug Safety)

About the role

The PV Specialist (Drug Safety) supports the management, maintenance and continuous improvement of Viatris' pharmacovigilance system in the assigned country. The role ensures compliance with local and global PV regulations and guidelines while safeguarding patient safety.

Key responsibilities

• Provide after‑hours availability when required by local regulations.
• Manage Individual Case Safety Reports (ICSRs) – receipt, documentation, forwarding, tracking and follow‑up.
• Collect safety data from interventional and non‑interventional studies, registries, and customer engagement programs.
• Screen Viatris‑sponsored social media and local language medical literature for safety information.
• Maintain patient confidentiality in line with applicable laws.
• Coordinate periodic safety reporting, including PSUR preparation with local regulatory affairs.
• Monitor affiliate PV system performance, report monthly compliance metrics and ensure timely ICSR submissions.
• Track changes in local PV legislation and communicate impacts to global teams.
• Maintain PV mailbox, phone and fax functionality and manage PV personnel changes with authorities.

Required profile

• Strong knowledge of national and international pharmacovigilance regulations and guidelines.
• Experience handling safety data from clinical trials, registries and real‑world data sources.
• Ability to work with cross‑functional teams and ensure accurate, timely reporting.
• Attention to detail and commitment to patient privacy.

Required skills

What we offer

• Opportunity to work within a global pharmaceutical company.
• Exposure to a wide range of safety data sources and regulatory environments.
• Professional development in pharmacovigilance and drug safety.