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 Japan. In this role, the CSH for Japan:

• Is the face of the Sanofi Patient Safety & Pharmacovigilance organization in Japan

• Is nominated as local Responsible Person for Pharmacovigilance / Safety Supervisor (“Anseki”).

• Serves as the local PV contact for Japanese Health Authorities (PMDA/MHLW), being accountable for Local PV inspections.

• Is accountable for all PV related activities in Japan 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 Japan.

• Ensures collaboration with local cross-functional teams to ensure required PV aspects are integrated into product launch and life-cycle management strategies.

• Oversees Japan country PV budget prioritization, resource allocation and outsourced activities.

• Ensures effective talent management through development and succession plans.

• Fosters synergies across the Key Markets PV country teams and facilitates best-practice sharing to ensure efficient and proactive PV services in a cost-effective way.

• 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 Head of R&D, Regulatory, Clinical, Quality, Medical/Medical Information, Commercial, Legal and Country Lead to support the business needs. The incumbent belongs to Sanofi Japan Division Heads and Japan MRPCQ Council, supporting the Country Council strategic goals implementation.

• Is expected to have a strong external interface with Japan trade industry, Japan Health Authorities (PMDA/MHLW) and patient safety organisations, as applicable

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/Japanese pharmacovigilance regulations, health-regulated legislations and local Life Science environments.

• Competent in leveraging digital tools and platforms to enhance efficiency and compliance.

Education:

Medical Doctor (MD) or Pharm D (Doctor of Pharmacy) strongly preferred

Languages:

Fluency in written and spoken Japanese and English is essential

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