Emmanuelle Pinès | Head of Safety Policy & Process Oversight, QPPV Office
Janssen

I am Head of the “Safety Policy and Process Oversight” group within the Johnson and Johnson Innovative Medicine QPPV office.  Ijoined Janssen in 2017 as PV Domain Expert in the Janssen Quality organization in charge of Pharmacovigilance audits activities. I moved to the QPPV Office in 2019 as Director, Pharmacovigilance System Oversight, supporting the QPPV office in overseeing Janssen Pharmacovigilance System, and Pharmacovigilance System Master File (PSMF) before being appointed in my current role. I have has more than 30 years of wide-ranging clinical, National Health Authority, Pharmaceutical industry and CRO experience and expertise in Pharmacovigilance, quality systems and clinical development. I served in various positions as Specialized physician in French Hospitals, Vaccines Clinical trial project leader at Pasteur Merieux Connaught (Sanofi Pasteur), Pharmacovigilance physician at Roche, Head of international PV department/EU QPPV at Guerbet and Head of Corporate Vigilances at Pierre Fabre as well as PV Inspector at ANSM (French Health Authority). I was as Member of the EMA taskforce for the implementation of the 2010 EU PV legislation as Co-chair of the project group on “Audit-inspection” in charge of coordinating the technical contribution to the EU Commission Implementing Regulation on Quality Systems for Pharmacovigilance systems and drafting GVP Modules I, II, III and IV.