In the position as PV Operational Associate, we are offering you an opportunity to play a key role in ensuring safe, compliant, and high-performing pharmacovigilance systems across our Regional PV Team. You’ll join a dynamic work community, supported by knowledgeable colleagues and continuous learning opportunities. Reporting to the PV Operational Team Lead, this role is central to our commitment to patient safety and regulatory excellence.

This position is accountable for executing day-to-day PV operations and compliance activities, to maintain robust pharmacovigilance systems primarily toward the Finnish affiliate, as well as where required, the Scandinavian affiliate.  You will ensure regulatory and company standards are met, supporting AbbVie’s dedication to quality and safety. The position is based in our Helsinki office.

Your responsibilities may include:

• Support the provision of PV system metrics, maintaining oversight of all performance indicators for compliance with local regulations and AbbVie’s internal standards.
• Develop, maintain, and continuously improve local/regional quality management procedures in accordance with both corporate and country-specific requirements.
• Perform impact assessments for new or updated corporate policies/processes, and support PV exception reporting, CAPA management, and business continuity plans/testing.
• Individual Case Safety Report (ICSR) activities: case recording, follow-up,  literature review, ongoing reconciliation, and robust quality control.
• Assist with internal audits, audits of affiliate service providers/partners, and regulatory PV inspections. Support CAPA development and timely execution of corrective actions.
• Ensure all PV requirements are in place for activities with potential identification or handling of safety information, always maintaining full compliance.
• Maintain PV training compliance and develop training materials, overseeing a comprehensive PV Training Matrix.
• Monitor and assess the impact of local and regional PV legislation/intelligence, ensuring processes are continuously updated.