PRIMARY FUNCTION:

• Responsible to ensure that all aspects of Pharmacovigilance at the affiliate level meets AbbVies statutory and ethical responsibilities and complies with local and regional PV regulations for the applicable product portfolio.
• Acts as the Affiliates lead for pharmacovigilance matters with the National Regulatory Agency and AbbVie PSEQ (Pharmacovigilance and Patient Safety Epidemiology and Research & Development Quality Assurance) function.
• (National QPPV / back-up National QPPV only) Serves as the local Qualified Person for Pharmacovigilance (QPPV) with sufficient authority to influence the performance of the quality system and pharmacovigilance activities and to promote maintain and improve compliance with the legal requirements