Head QPPV & PRRC Office in Wehr bei Novartis

Head QPPV & PRRC Office (f/m/d) in Wehr bei Novartis

Novartis

384853BR

Head QPPV & PRRC Office (f/m/d)

Germany

About the role

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.

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Role Requirements

PhD or MD with a high level of expertise in PV including aspects of medical safety gained in a European environment (minimum of 10 years) including preferably experience in a major EU/EEA country or the UK
Excellent knowledge of European (regional and national, including the UK) regulatory requirements relating to PV
PV systems experience (covering compliance, databases, procedures, QA, training)
Direct experience of GxP audits and regulatory inspections
Management experience regarding managing a Patient Safety or Regulatory Affairs team (line or functional management)
Excellent stakeholder management including Health Authorities and other key external interfaces
Excellent communication and interpersonal skills with the ability to engage and influence at all levels.
Excellent command of English, both oral and written

It's a hybrid work model and you can work also form other Novartis offices in Germany.

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

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