About the Job
The Patient Safety & Pharmacovigilance (PSPV) aspiration is to be a cutting-age safety group, to enable Sanofi to optimize the benefit-risk of our therapies, so we can best serve our patients and consumers.
The PV Regions group is an international, dynamic, and culturally diverse team dedicated to the safety of Sanofi products in regions/countries.
The Country Safety Head ensures that local PV activities are performed in compliance with the global/regional/local PV regulations and PSPV Quality Documents (QDs) to warrant safe and appropriate use of Sanofi products in the assigned country.
CSH Main responsibilities:
The face of the Safety organization in the country
Accountable for all PV related activities in the country & ensures that the local PV teams are properly trained to manage these activities.
Ensures inspection readiness of the PV system in the country, serves as the local PV contact for the local authorities and acts as the local Responsible Person for Pharmacovigilance (RPP) where applicable per country legislation (this role can be delegated as needed)
Builds & maintains all necessary relations/collaboration with the key PSPV stakeholders as well as other CSHs, and with the in-country partner functions (including but not limited to Medical, Regulatory, Quality, Commercial, Legal, and Country Leads).
Accountable for local PV outsourced activities and PV compliance of local partnerships
Accountable for local PV resources and budget with both local & global supporting functions
Oversight of the Export Market of Brunei
Accountable for ensuring PV activities are managed by the Export Market Partners are compliant as per PVA and PV requirements in the perimeter, including promoting actions to make the partner raise to the required compliance levels.
About You
Strong experience with PV systems & Regulatory Agency interactions
Strong leadership
Able to create networks and to collaborate in an international cross-functional environment.
Self–motivated, ruthlessly prioritize to deliver most value.
Solution oriented & strategic thinking while keeping patients and customers top of mind.
Good communicator with attention to detail while seeing the big picture.
Oversight of the Export Market of Brunei: Good persuasion, negotiation and influencing skills, notably for Partner Market Service Providers interactions.
Strong knowledge of pharmacovigilance systems & regulations
Good understanding of how to manage safety data from multiple sources
Able to evaluate & manage safety signals and define risk management activities
Advanced health care discipline degree (MD, PharmD, PhD, Master of Science, etc.) or equivalent qualification
Full professional English language proficiency
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 and check out our Diversity Equity and Inclusion actions at sanofi.com!
Top Skills
What We Do
We are Sanofi, an innovative global healthcare company. We chase the miracles of science to improve people’s lives.
Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.
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