Job summary
This senior role in pharmacovigilance supports global veterinary health compliance activities, ensuring adherence to regulatory requirements across the EU. The position includes responsibility for managing procedures, training, audits, inspections, pharmacovigilance agreements, and compliance reporting, as well as deputizing for the Qualified Person for Pharmacovigilance (QPPV) in EU and UK matters. The role requires a veterinary medicine degree and experience in regulated industry pharmacovigilance, with strong English communication skills and the ability to work independently in a multicultural environment.
Location and work setup
- Location
- Norway
- Work setup
- On-site
Responsibilities
Lead development and management of global pharmacovigilance procedures and training programs. Oversee lifecycle and compliance of pharmacovigilance agreements. Coordinate compliance reporting and metrics with internal and external stakeholders. Support and manage pharmacovigilance audits, inspections, corrective actions (CAPA), and maintenance of Pharmacovigilance System Master File (PSMF). Serve as a primary liaison between pharmacovigilance, quality assurance, and external partners. Deputize for the EU/UK QPPV, including regulatory authority interactions and pharmacovigilance oversight. Provide strategic guidance on pharmacovigilance activities focused on benefit-risk monitoring. Drive continuous improvement initiatives to enhance compliance and operational effectiveness across the global pharmacovigilance organization.
Qualifications
A degree in Veterinary Medicine with a minimum of three years' experience in the regulated industry, preferably focused on pharmacovigilance. In-depth knowledge of veterinary pharmacovigilance regulations, especially within the EU. Strong English language proficiency. Preferred qualifications include demonstrated ability to work autonomously and make decisions independently, a quality and compliance-driven mindset, capability to lead complex compliance projects, experience with regulatory authorities and audits in the EU, and demonstrated teamwork in multicultural and cross-functional environments.