The Head QPPV & PRRC Office has the dual accountability of
(1) acting as the EU Qualified Person for Pharmacovigilance (QPPV) and UK QPPV including the responsibility for the global Novartis Pharmacovigilance (PV) system, safety profiles and any emerging safety concerns in relation to the Novartis medicinal products and combined medical devices and
(2) heading the QPPV & Person Responsible for Regulatory Compliance (PRRC) Office.
The role reports to the Head Patient Safety & Pharmacovigilance (PS&PV) and is a key member of the PS&PV Leadership Team.
Key Responsibilities:
- Accountable for ensuring oversight of the expedited and aggregate reporting of all suspected adverse reactions received by Novartis to health authorities worldwide.
- Oversight of the structure and performance of the Novartis global PV system in order to promote, maintain and (where possible) improve compliance.
- Ensures timeliness and good quality during the preparation of PV reports for Competent Authorities of the Member States where the medicinal product is authorized and the UK National Competent Authority.
- Ensures that post-authorization commitments are fulfilled in accordance with regulatory requirements working in collaboration with Regulatory Affairs, Medical Safety and Safety Sciences.
- Ensures full and prompt answers are provided to all PV requests from the EU/EEA Competent Authorities, or from UK National Competent Authority, for the provision of additional information necessary for the evaluation of the benefits and the risks afforded by a medicinal product.
- Conducts continuous overall PV evaluation during the post-authorization period including oversight of PV operations in Europe/EEA and non-EU/EEA countries, especially the UK, with QPPV requirements to ensure complete oversight of the structure and performance in country systems and across Patient Safety.
- Acts as a point of contact for the Novartis group of companies for the EMA, UK, and any National Competent Authorities (as required) on a 24-hour basis and manages/cascades safety related requests for systems or safety-related information to ensure any requests are answered fully and promptly.
- Assesses the impact of new pharmacovigilance related legislation with a focus on EU/EEA and the UK and provide strategic support to Development on EU/EEA/UK pharmacovigilance matters on strategic impact of any changes.
- Fulfills the requirements of the Person Responsible for Regulatory Compliance (PRRC) for medical devices including ensuring their conformity with the Novartis quality management system and leading safety evaluations regarding post-market surveillance obligations.
- Contributes to the Medical Safety Review Board and Portfolio Stewardship Board and ensures appropriate awareness of emerging safety concerns and safety profiles of medicinal products for which the Novartis group of companies MAHs holds marketing authorizations.