Join AbbVie as the Pharmacovigilance (PV) Specialist, serving as the National Qualified Person for Pharmacovigilance (QPPV) Deputy for Serbia. In this key compliance role, you will be accountable for executing the day-to-day operations and compliance activities to maintain high-functioning PV systems across Serbia and Bosnia and Herzegovina.

You will directly support the maintenance and oversight of our local PV system, ensuring alignment with AbbVie’s global standards and Serbian regulatory requirements. Appointed as the National QPPV Deputy in Serbia, you will have authority to influence the performance of the quality system and PV activities and to promote, maintain and improve compliance with the legal requirements.

Key Responsibilities:

• Oversee and maintain accuracy of the Pharmacovigilance System Master File (PSMF), ensuring all documentation is up-to-date and compliant.
• Support the provision of metrics that will ensure oversight of all aspects of the performance and functioning of the PV system in compliance with local regulations and internal company timelines/standards.
• Develop and maintain local and regional SOPs and procedures, in alignment with AbbVie’s corporate guidance and local legislation.
• Manage Individual Case Safety Reports (ICSRs): processing, conducting follow up, expedited reporting, quality control, reconciliation, and tracking. Perform medical or scientific literature review.
• Periodic safety reporting (e.g., PSURs, DSURs, SUSAR Line Listings): review, preparation, submission, and evidence documentation.
• Lead/support internal PV audits, regulatory inspections, and CAPA processes including timely action tracking to completion.
• Ensure all PV requirements are in place for activities where there is a reasonable possibility for the identification and/or handling of safety information in accordance with AbbVie procedures and local requirements.
• Oversee PV training compliance and the development/maintenance of the PV training materials and training matrix.
• Monitor and assess changes in local/regional PV legislation, ensuring prompt impact assessment and implementation.
• Lead/support affiliate risk management activities, including RMPs, aRMM, and local implementation plans.
• Ensures availability to be at AbbVie’s disposal continuously on a 24-hour basis, and that an after-hours process is in place for the reporting of AEs and that a Business Continuity Plan is established to allow for continuation of critical business processes for PV.