Poste rédigé en anglais : au vu du caractère international du poste, il est indispensable que le / la candidat(e) retenu(e) parle couramment anglais.
Integrated into the Global Safety Science Risk team of the Global Pharmacovigilance Department, you will join a team covering all of Sanofi’s therapeutic Areas (except Vaccines).
As Risk Management Expert (RME) , your main responsibilities will be to :
Provide expertise & leadership in pre and post marketing risk management for marketed and investigational products supporting global, regional and local safety teams
Determine appropriate product risk minimization strategy for ensuring patient safety in light of benefit / risk assessment in coordination with relevant functions & regulators before senior committee endorsement.
Ensure the development of Risk Management Plan (RMP) documents by leading the cross-functional team, involving the appropriate experts for contributing to this regulatory document part of submission dossiers (eg, pharmacovigilance, epidemiology, medical, regulatory, etc)
Supervise globally the appropriate implementation of risk minimization activities beyond routine for concerned products
Deliver RMP trainings to internal and / or external audience.
Participate to specific strategic projects where RMP expertise is required,
Educational background & experience
M.D., Pharm D, PhD , Msc sciences
A minimum of 5-year experience in pharmacovigilance or relevant medical field (e.g., clinical development, regulatory area , toxicology or pharmacoepidemiology,
Knowledge / background in epidemiology area or product risk management
Involvement in management of public health risks or clinical safety data analysis.
Skills & Competencies
Leadership to manage cross-functional multicultural team and face safety crisis
Ability to work and deliver under pressure with competing priorities and timelines
Collaboration skills to interact transversally with various functions (global, regional and local) including interface with vendors,
Ability to use computerized systems to manage documents ( eDMS, ..)
Fluent in English.
At Sanofi diversity and inclusion are foundational to how we operate and are embedded in our values. We respect the diversity of our people, their backgrounds and experiences.
We recognize that to benefit from the wealth that diversity brings, we must lead with inclusion and have a workplace where differences can thrive and be leveraged to empower the lives of patients!
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health.
We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-
term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life