This job post is subject to local legal and social procedures where applicable. (Soumis aux procédures légales et sociales locales, le cas échéant.)

Job title: PV Excellence Manager

• Location: Gentilly
• Job type: Permanent
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About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our French Patient Safety and Pharmacovigilance Team (PSPV) as PV Excellence Manager in the PV Excellence Team.

Pharmacovigilance is a strongly regulated area and the PV excellence team plays a key role in the performance, compliance and oversight of the French PSPV processes within the global PSPV department. PV Excellence team interacts with multiple stakeholders at local and corporate level. This position is key to our PV missions, the main one being to ensure patient safety. The entire French PSPV team is a nice, dynamic and dedicated team.

Main responsibilities:

Reporting to the PV Excellence Lead, the incumbent is responsible of:

• The conduct and oversight of ICSR follow-up requests management in compliance with regulations and internal standards, including pre-litigation cases in collaboration with local legal department
• The management of the PBRER planning for local needs including analysis of regulatory events within the lifecycle of products in collaboration with global PSPV team and local stakeholders (Regulatory and Medical teams)
• The maintenance and oversight of the local PV system including local PSPV QD management, PV training to PV and non-PV personals, compliance KPIs follow-up, PV deviations and related action plans management, local PSPV inspection readiness and oversight of vendors involved in PV activities
• The management, assessment and oversight of all types of contracts where PV activities are included or PV clauses are required (acquisitions, divestments, studies, programs) in collaboration with local and global stakeholders
• The proper processing and knowledge of Materiovigilance and Reactovigilance (DM/DIV), in interactions with product managers and other functions (Local Quality, Regulatory Affairs and France PV Operations)
• Being a referent for PV activities within all types of studies to ensure oversight and homogeneity of the related documents and processes in interaction with local PSPV product and compliance managers and other functions (Global PSPV Operations, Local Medical Affairs, Clinical Study Unit (CSU) and the EU CSU Regional Clinical Safety Lead)
  

About you

• Experience: 2-5 years in Pharmacovigilance in pharmaceutical industry or at Health Authorties’
• Soft and technical skills: team spirit, rigor, great communication and relationship-building skills, familiar with digital tools. Good knowledge of PV regulations both at French and EU level (Bonnes Pratiques de Pharmacovigilance, GVP guidelines)
• Education: Pharmacist
• Languages: French bilingual, English intermediate
  

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave
• Play an instrumental part in supporting best practice within French PV department to support patient safety