Multi Country Safety Head
- Location: Bogotá, Colombia
- Type of role: Permanent / Full time
About the job
The Patient Safety & Pharmacovigilance (PSPV) aspiration is to be a cutting-age safety group, to enable us 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 QDs to warrant safe and appropriate use of Sanofi products in the assigned country (or countries for the M-CSH).
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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)
- Operates as Local Safety Officer (LSO) by managing medical safety of assigned local products under the oversight of the Regions Medical Safety Head (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 Lead).
- 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
- Multi-Country Safety Head (M-CSH) by managing the CSH(s) and overseeing the PV activities and compliance of countries under his/her perimeter
About you
Experience:
- Experience with pharmacovigilance systems and safety related product management in both clinical development and marketed products
- Strong experience with PV Systems & Regulatory Agency Interactions
- Managerial experience in an international environment
- Strong Leadership, able to create networks and to collaborate in an international cross-functional environment
- Interpersonal Relationships
- Personal Leadership
- 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
- 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
General competencies:
- As the local Responsible Person for Pharmacovigilance (RPP), the CSH must fulfill the local requirements applicable per country legislation
- The CSH must demonstrate sufficient proficiency in English (verbal and written) to accurately communicate PV information outside his/her country(ies)
- Strong knowledge and expertise in national (pharmacovigilance including medical products and vaccines, medical devices, cosmetics, nutraceuticals when relevant) regulations and international regulations as well as industry standards
Key functional competencies
- Medical Safety Landscape
Sufficient ability to interpret clinical data including safety data.
- Signal Detection: Safety Surveillance & Data Gathering
- Signal Assessment & Risk Identification
- Risk Management
Key functional competencies (continued)
- Benefit/Risk Assessment & Optimization
- Insight Generation & Customer Engagement
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