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- Deputize for CSH: Replace the Country Safety Head (CSH) in their absence, act as local PV contact for authorities, and be accountable for PV inspections.
- Compliance: Support the CSH in ensuring local PV activities comply with PSPV policies and global, regional, and local PV regulations to ensure safe use of Sanofi products.
- System Maintenance: Assist in establishing and maintaining a robust and efficient local PV system, ensuring proper systems, procedures, tools, and training are in place.
- Local Safety Officer (LSO): Optionally, manage the medical safety of assigned local products under the oversight of the Regional Medical Safety Head (RMSH).
- Authority Liaison: Serve as the local PV contact for local authorities and act as the local Responsible Person for Pharmacovigilance (RPP) as required by country legislation.
Experience:
- Pharmacovigilance Systems: Experience with pharmacovigilance systems and safety-related product management in both clinical development and marketed products.
- Minimum Experience: Experience in pharmacovigilance, regulatory, quality, medical, or clinical development.
- Documentation Standards: Experience with high-quality safety documents such as RMP, PBRER is a plus.
- Regulatory Interactions: Experience interacting with Regulatory Agencies.
Soft Skills:
- Leadership: Ability to create networks and collaborate in an international cross-functional environment.
- Interpersonal Skills: Diplomacy, team player dynamics, respect for cultural differences, professionalism, and mediation.
- Problem Solving: Strong problem-solving skills and sense of urgency, particularly regarding safety rules and global procedures.
- Pressure Handling: Ability to work under pressure and in international and transversal teams.
Technical Skills:
- Pharmacovigilance Knowledge: Robust knowledge of pharmacovigilance systems and regulations.
- Clinical Data Interpretation: Ability to interpret clinical and safety data.
- Safety Management: Capability to evaluate and manage safety signals and define risk management activities.
Education:
- Advanced health care discipline degree (M.Pharmacy, B.Pharmacy, or MBBS) or equivalent qualification with 5 years of experience.
Languages:
- Professional English language proficiency.
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