Pharmacovigilance Specialist, NQPPV Deputy Serbia

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

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.

• Degree qualifications from Faculty of Medicine, Faculty of Pharmacy or Faculty of Dental Medicine (dentistry).
• Resident of Serbia.
• Fluent in Serbian and a strong command of English. 
• A minimum of 1 year of experience in the pharmacovigilance field is required.
• In-depth knowledge of Serbian PV regulations and GVP requirements.
• Strong organizational, analytical, and communication skills.
• Ability to work independently with high attention to detail and compliance.
• Multilingual capabilities, particularly proficiency in the Slovenian language, will be regarded as an advantage.

We offer a very dynamic environment, abundant opportunities for professional growth and development, exposure to diverse cultures within the region, and the chance to collaborate closely with senior leaders. This combination creates a unique and rewarding workplace where individuals can learn, contribute, and advance their careers. Ready to make an impact? Apply now and help us ensure the highest standards of product safety for patients.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html