Milano, ITA
1 day ago
Country Safety Head Italy & Malta
**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. Watch ‘One day at Sanofi’ (https://www.youtube.com/watch?v=ugcobndkKKo) and check out our Diversity Equity and Inclusion initiatives at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) \#LI-EUR \#LI-HYBRID **Pursue** **_progress_** **, discover** **_extraordinary_** Better 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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
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