Company Description

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 (https://www.tiktok.com/@abbvie) .

Job Description

We are recruiting Pharmacovigilance Specialist, N-QPPV Serbia to join our diverse team. The successful candidate will coordinate and execute all aspects of pharmacovigilance (PV) at the Serbian affiliate to ensure that all of AbbVie’s statutory and ethical responsibilities are met. They will act as the Affiliate’s contact point for pharmacovigilance matters with the National Regulatory Agency and AbbVie Pharmacovigilance and Patient Safety (PPS) function.

Main responsibilities:

Maintain oversight of areas of responsibility of the affiliate PV compliance status and escalate compliance issues in a timely manner

Maintain awareness and monitor local post-marketing and clinical PV legislation, to ensure PV legislation changes are communicated to relevant stakeholders for review, impact assessment, implementation, and mitigation according to global procedures.

Comply with local and regional PV regulations and the Affiliate PV System procedure(s)

Monitor training compliance of affiliate personnel according to local contract requirements.

Manage any non-conformity and/or planned departures from corporate and/or local PV procedures according to the global issue and exception management process and ensure any corrective/preventive actions are completed according to the schedule.

Oversight of reporting of both clinical and post-marketing Individual Case Safety Reports (ICSRs) and Periodic and Aggregate Reports to the Regulatory Agency, Ethics Committees and Investigators, to comply with corporate PV procedures and with local and regional PV regulations as required.

For assigned projects, partner with Program Owners to ensure that all business partnerships involving activities where there is a reasonable possibility for the identification and/or handling of safety information are assessed for the generation of safety information and the applicable PV requirements are applied in accordance with AbbVie procedures and local requirements. Maintain and monitor compliance with local agreement

Support both internal PV audits and Regulatory Agency PV inspections.

Ensure a full and prompt response to regulatory agency requests assigned, for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product.

Ensure that a Disaster Recovery Plan/Business Continuity Plan is followed in a risk-based manner to allow for continuation of critical business processes for PV.

Maintain system oversight and overview of the safety profiles of all products.

Ensure availability to be at AbbVie’s disposal permanently and continuously on a 24-hour basis.

Qualifications

Medicine, Dental Medicine or Pharmacy degree.

Experience of working in the pharmaceutical industry in a drug safety role 1-3 years

Demonstrated attention to detail.

Excellent written and spoken communication and presentation skills.

Fluency in written and oral English is highly desirable in order to facilitate communications with Global Pharmacovigilance, Regional Medical and other headquarters functions.

Fluency in written and oral local language a requirement in order to facilitate communications within the affiliate medical department, and with the National Regulatory Authority.

High customer orientation

Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity

Sound judgment, strong planning and organizational skills, and the ability to get things done. Demonstrated strong sense of urgency.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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