Vaccines Patient Safety & Pharmacovigilance Head

Sanofi

Lyon, France

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:

Is accountable to define the overall patient safety strategy for the GBU of Discovery to Development and in post marketing settings;
Is accountable for the maintenance of up-to date safety risk profiles of the GBU’s products;
Supports the Chief Safety Officer and the other PSPV leaders in developing and deploying the global strategy and vision for PSPV;
Leads safety crisis by guiding muti-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;
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;
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 pharmaceutical industry including direct interaction with key regulatory agencies, experience in post-marketing and clinical development pharmacovigilance;
In-depth working knowledge of regulatory environment;
Lively experience in leading medium/large sized organizations (including resources management) or matrix teams, in managing change, and in 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 area.

Soft skills:

Effective and agile communicator on complex clinical topics and product benefit-risk;
Ability to foster innovation at the workplace;
Collaborative mindset and ability to built trust with internal and external stakeholders;
Strong patient focus and understanding of benefit/risk considerations.