Country Safety Head Italy & Malta

• Location: Milan, Italy

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 the assigned countries and is the face of the Patient Safety organization in Italy and Malta.

Main responsibilities:

• Serves as the local PV contact for AIFA/Malta Medicines Health Authority.

• Is accountable for all PV related activities in the assigned countries & ensures that the local PV teams are properly trained to manage these activities.

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

• Provides guidance to the Country Safety Officers for the maintenance and optimization of the country PV system.

• Ensures inspection readiness of the PV systems in Italy and Malta.

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

• Ensures effective talent management through development and succession plans.

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 pharmacovigilance international/EU regulations, health-regulated legislations and local Life Science environments; competent in leveraging digital tools and platforms to enhance efficiency and compliance.
• Education: Advanced degree in Life Sciences, Pharmacy, Medicine, or other healthcare related profession. Preferred: Master’s or Doctorate degree in a healthcare related field.
• Languages: Fluency in written and spoken English is essential.

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.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• 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 weeks’ gender-neutral parental leave.

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