MTL Country Safety Head
Sanofi
Employer Active
Posted 3 hrs ago
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Nationality
Any Nationality
Gender
Not Mentioned
Vacancy
1 Vacancy
Job Description
Roles & Responsibilities
- The face of the Patient Safety & PV organization in Morocco, Tunisia & Libya
- Accountable for all PV related activities in Morocco, Tunisia and Libya & ensures that the local PV teams are properly trained to manage these activities (when applicable)
- Ensures inspection readiness of the PV system in the countries, serves as the local Qualified Person for Pharmacovigilance (QPPV)for the Moroccan Health authorities where applicable
- 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
- 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)
- Strong experience with PV systems & Regulatory Agency interactions (minimum of 3 years Pharmacovigilance experience)
- 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.
Technical skills:
- 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
Pharmacist with competencies in epidemiology and biostatistics
Languages: Full professional English & French languages proficiency
Desired Candidate Profile
- Strong experience with PV systems & Regulatory Agency interactions (minimum of 3 years Pharmacovigilance experience)
Company Industry
- Pharma
- Biotech
- Clinical Research
Department / Functional Area
- Administration
Keywords
- MTL Country Safety Head
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Sanofi
About Sanofi: We re an R&D-driven, AI-powered biopharma company committed to improving people s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people s lives. About the job Accountable for ensuring Export Market Service Providers/Partners PV activities are compliant as per PVA and PV requirements in Tunisia and Libya, including promoting actions to make the partner raise to the required compliance levels if applicable.
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