Ingénieur Devops

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-age 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

The GBU Vaccines Patient Safety & Pharmacovigilance Head :

1. Is accountable to define the overall patient safety strategy for the GBU of Discovery to Development and in post-marketing settings
2. Is accountable for the maintenance of up-to-date safety risk profiles of the GBU’s products
3. Supports the Chief Safety Officer and the other PSPV leaders in developing and deploying the global strategy and vision for PSPV
4. 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
5. Leads and manages an international team of Therapeutic Area Heads and Global Safety Officers, fostering alignment on PV positions in interfacing with relevant stakeholders
6. Chairs / Co-chairs safety governance bodies for adjudication of signals ensuring a thorough assessment and strategic decision with respect to risk management and benefit-risk for the GBU products
7. Fosters aligned communication of product benefit-risk across the GBU with the support of key cross-functional stakeholders
8. 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

1. Experience :
2. Strong track record of pharmacovigilance in the pharmaceutical industry including direct interaction with key regulatory agencies, experience in post-marketing and clinical development pharmacovigilance
3. In-depth working knowledge of the regulatory environment
4. Extensive experience in leading medium/large-sized organizations (including resource management) or matrix teams, in managing change, and in developing and mentoring teams
5. Strong scientific and medical background and excellent critical data analysis skills (clinical/systems/processes/compliance)
6. Clinical or industry experience in relevant therapeutic areas
7. Effective and agile communicator on complex clinical topics and product benefit-risk
8. Ability to foster innovation in the workplace
9. Collaborative mindset and ability to build trust with internal and external stakeholders
10. Strong patient focus and understanding of benefit/risk considerations
11. Education : Medical Doctor preferred or advanced health care discipline degree (PharmD, PhD, etc.) specialized in relevant areas in the pharmaceutical industry
12. Languages : Full professional English language proficiency