Job title: Country Safety Head France/Local Responsible Person for Pharmacovigilance for Sanofi Winthrop Industry

• Location: Gentilly

About the job

The 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:

Main responsibilities (CSH for France):

• Is the face of the Sanofi Patient Safety organization in France and leads the French Pharmacovigilance team
• Is 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 inspections
• Is accountable for all PV related activities in France and ensures that the local PV teams are properly trained to manage these activities
• Set up and manage the optimization of the PV system in the national territory
• Ensures audit and inspection readiness of the PV system in France
• Ensures collaboration with local cross-functional teams to ensure required PV aspects are integrated into product launch and life-cycle management strategies
• Oversees France country PV budget prioritization, resource allocation and outsourced activities
• Ensures effective talent management through team development and succession plans
• Fosters 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 way
• Is expected to have a strong external interface with French trade industry (LEEM), French Health Authorities (ANSM) and related patient safety organisations

Builds & maintains successful collaboration with:

• Key PSPV stakeholders, such as other CSHs within the Regional PSPV organization
• In-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 implementation

About you

Experience:

• Proven and sustained experience in Pharmacovigilance/Health-regulated activities, including strategic interactions with regulatory agencies
• Extensive managerial experience in local and international setting, successfully leading teams and ensuring compliance across diverse regulatory landscapes

Soft and technical skills:

• A strong leader and motivator, skilled in building networks and fostering collaboration within international cross-functional teams
• Excellent verbal and written communication skills, effectively engaging stakeholders across various levels
• Customer-Focused Approach: Adept at working with both country representatives and global stakeholders in dynamic, evolving environments
• Strategic Thinking: Capable of independently managing multiple priorities, applying intentional and rational thought to drive long-term success
• Decision-Making & Problem-Solving: Able to confidently navigate complex industry challenges, define problems, and develop solutions with sound business judgment, balancing risk and benefit effectively
• Extensive understanding of International/EU/French pharmacovigilance regulations, health-regulated legislations, and local Life Science environments
• Competent in leveraging digital tools and platforms to enhance efficiency and compliance

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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 essential

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