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Country Safety Head Malaysia and Brunei
SanofiPetaling Jaya, Selangor, Malaysia9 hours ago
Job descriptionStrong 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
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.
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Malaysia • Petaling Jaya, Selangor, Malaysia