Manager Adjoint (H / F), en alternance

Vision Systems; Saint-Fons; Sur place; EUR 20 000 - 40 000; Plein temps

Résumé du poste

An innovative global healthcare company is seeking a Vaccines Patient Safety & Pharmacovigilance Head to lead strategic safety initiatives. This role involves defining the patient safety strategy, managing risk profiles, and guiding an international team to ensure patient safety and compliance. You will collaborate with key stakeholders, represent safety matters in governance bodies, and drive effective communication regarding product benefit-risk. This is a unique opportunity to make a significant impact in a dynamic and culturally diverse environment, where your expertise in pharmacovigilance and leadership will be crucial in shaping the future of vaccine safety.

Qualifications

• Strong track record in pharmacovigilance with regulatory agencies.
• Experience in managing medium/large teams and change.

Responsabilités

• Define patient safety strategy for GBU in development and post-marketing.
• Lead safety crisis management and guide multi-functional teams.

Connaissances

Pharmacovigilance

Data Analysis

Regulatory Knowledge

Leadership

Communication

Innovation

Patient Focus

Formation

Medical Doctor

PharmD

PhD

Description du poste

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, care givers and health care professionals.

Our Pharmacovigilance Group is an international, dynamic, and culturally diverse team working across the globe.

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 crisis 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. Chair / Co-chair 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 pharmaceutical industry including direct interaction with key regulatory agencies, experience in post-marketing and clinical development pharmacovigilance
3. In-depth working knowledge of regulatory environment
4. Lively experience in leading medium / large sized organizations (including resources 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 area
7. Effective and agile communicator on complex clinical topics and product benefit-risk
8. Ability to foster innovation at 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