Job Title : Vaccines Patient Safety & Pharmacovigilance Head
Location : Lyon, France (1st priority)
About Sanofi
We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.
Our Team
The Global Patient Safety Pharmacovigilance (PSPV) aspiration is to be a cutting-edge safety group, to enable us to optimize the benefit-risk profiles of our therapies, so we can best serve patients, caregivers, and healthcare professionals.
The PV GBU Head is accountable for all safety-related and risk management activities feeding into the benefit-risk profile of the Global Business Unit throughout the life cycle of products in development and post-marketing. The PV GBU Head provides strategic PV input and direction across the GBU in partnership with other stakeholders.
Main Responsibilities
- Accountable to define the overall patient safety strategy for the GBU from Discovery to Development and in post-marketing settings.
- Accountable for the maintenance of up-to-date safety risk profiles of the GBU’s products.
- Supports the Chief Safety Officer and other PSPV leaders in developing and deploying the global strategy and vision for PSPV.
- Leads safety crises by guiding multi-functional teams in evidence-based decision-making with patient safety first in mind and the impact on public health.
- Leads and manages an international team of Therapeutic Area Heads and Global Safety Officers, fostering alignment on PV positions in interfacing with relevant stakeholders.
- Chairs/Co-chairs safety governance bodies for adjudication of signals ensuring thorough assessment and strategic decision-making with respect to risk management and benefit-risk for the GBU products.
- Fosters aligned communication of product benefit-risk across the GBU with the support of key cross-functional stakeholders.
- Represents PSPV for safety matters on the GBU’s decision-making governance bodies and interacts with external stakeholders such as regulatory authorities, scientific experts, and professional associations.
About You
- Experience:
- Strong track record of pharmacovigilance in the pharmaceutical industry including direct interaction with key regulatory agencies, experience in post-marketing and clinical development pharmacovigilance.
- In-depth working knowledge of the regulatory environment.
- Extensive experience in leading medium/large sized organizations (including resource management) or matrix teams, managing change, and developing and mentoring teams.
- Strong scientific and medical background and excellent critical data analysis skills (clinical/systems/processes/compliance).
- Clinical or industry experience in relevant therapeutic areas.
- Effective and agile communicator on complex clinical topics and product benefit-risk.
- Ability to foster innovation in the workplace.
- Collaborative mindset and ability to build trust with internal and external stakeholders.
- Strong patient focus and understanding of benefit/risk considerations.
- Education: Medical Doctor preferred or advanced healthcare discipline degree (PharmD, PhD, etc.) specialized in relevant areas in the pharmaceutical industry.
- Languages: Full professional proficiency in English.