Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail.
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Job title: Country Safety Head France/Local Responsible Person for Pharmacovigilance for Sanofi Winthrop Industry
Location: GentillyAbout the jobThe Country Safety Head (CSH) ensures that local Pharmacovigilance (PV) activities are performed in compliance with the applicable PV regulations and quality documents to warrant safe and appropriate use of Sanofi products in France.
About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
Main responsibilities (CSH for France):
Is the face of the Sanofi Patient Safety organization in France and leads the French Pharmacovigilance teamIs nominated as local Responsible Person for Pharmacovigilance (“RPV”) by delegation of the Responsible Pharmacist (“Pharmacien Responsable”)Serves as the local PV contact for French Health Authorities (ANSM), being accountable for Local PV inspectionsIs accountable for all PV related activities in France and ensures that the local PV teams are properly trained to manage these activitiesSet up and manage the optimization of the PV system in the national territoryEnsures audit and inspection readiness of the PV system in FranceEnsures collaboration with local cross-functional teams to ensure required PV aspects are integrated into product launch and life-cycle management strategiesOversees France country PV budget prioritization, resource allocation and outsourced activitiesEnsures effective talent management through team development and succession plansFosters synergies across the Europe/Key Markets PV country teams and facilitates best-practice sharing to ensure efficient and proactive PV services in a cost-effective wayIs expected to have a strong external interface with French trade industry (LEEM), French Health Authorities (ANSM) and related patient safety organisationsBuilds & maintains successful collaboration with:
Key PSPV stakeholders, such as other CSHs within the Regional PSPV organizationIn-country partner functions, including but not limited to the Pharmacien Responsable, Regulatory, Clinical, Quality, Medical/Medical Information, Commercial, Legal departments and Country Lead to support the business needs. The incumbent is a member of the Sanofi France extended leadership team and MRPCQ Council, supporting the Country Council strategic goals implementationAbout youExperience:
Proven and sustained experience in Pharmacovigilance/Health-regulated activities, including strategic interactions with regulatory agenciesExtensive managerial experience in local and international setting, successfully leading teams and ensuring compliance across diverse regulatory landscapesSoft and technical skills:
A strong leader and motivator, skilled in building networks and fostering collaboration within international cross-functional teamsExcellent verbal and written communication skills, effectively engaging stakeholders across various levelsCustomer-Focused Approach: Adept at working with both country representatives and global stakeholders in dynamic, evolving environmentsStrategic Thinking: Capable of independently managing multiple priorities, applying intentional and rational thought to drive long-term successDecision-Making & Problem-Solving: Able to confidently navigate complex industry challenges, define problems, and develop solutions with sound business judgment, balancing risk and benefit effectivelyExtensive understanding of International/EU/French pharmacovigilance regulations, health-regulated legislations, and local Life Science environmentsCompetent in leveraging digital tools and platforms to enhance efficiency and compliance
Education:
Medical Doctor (MD) or Pharm D (Doctor of Pharmacy), as per local regulation requirement (BPPV)Languages:
Fluency in written and spoken French and English is essentialPursue Progress. Discover Extraordinary.
Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.
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Pursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!