Reference No: R2621583
Title: Director, Pharmacoepidemiologist
Department: Pharmacoepidemiology Pasteur
Location: Toronto, Ontario; Swiftwater, PA, or Bridgewater, NJ, USA; Lyon, France
Sanofi Pasteur: The world’s leading vaccine company
Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines. Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe. Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases.
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.
Position Summary :
The primary role of a Pharmacoepidemiologist is to provide pharmacoepidemiology expertise and product strategy to marketed and investigational vaccine products. More specifically, a Pharmacoepidemiologist designs and leads the implementation of post-authorization safety studies required by Regulatory authorities and other pharmacoepidemiology studies for internal and external use, and provides pharmacoepidemiology expertise within Global PV (Global Safety Officer, PV Scientist and others) and collaborates with other functions (Medical, Clinical, Regulatory, and others) within the company in order to align with vaccine product strategy.
Key Responsibilities :
Lead the development of pharmacoepidemiological studies and observational PASS including their design, conduct and interpretation in close collaboration with functions as needed (e.g. GSO, Medical, Regulatory, Biostatistics, Clinical Operations, countries).
Liaise with the other pharmaceutical companies and industry associations regarding collaborative studies as needed (e.g. Joint PASS).
Liaise with external pharmacoepidemiology experts as needed.
Pharmacoepidemiology support to Global PV safety analysis activities.
Conduct epidemiological literature review and/or analysis for signal evaluation and interpretation.
Prepare the pharmacoepidemiologic section of the Risk Management Plan(s) pertaining to drug/vaccine safety and formulate pharmacoepidemiology studies/action plan as appropriate.
Prepare responses to questions to health authorities regarding pharmacoepidemiology (epidemiological literature or epidemiological studies). Participate in Advisory Committee preparations.
Benefit-Risk Analysis: provide epidemiology support (as appropriate) for benefit-risk analyses.
Management of pharmacoepidemiological data.
Identify and determine efficient data collection approaches and RWD data sources relevant for the questions being investigated.
Be a point of contact and expert for pharmacoepidemiological support in the company notably: within GPV for Global Safety Officer, PV scientist, Risk Management Expert and Signal Management Expert for other functions such as Global Medical, Clinical Study Unit, RWE, Regulatory Affairs and Health economics and Value Access.
Keep abreast of changes in the regulatory, medical, scientific environment with respect to pharmacoepidemiological practices.
Participate in internal or external working groups requiring pharmacoepidemiology expertise.
Working groups for process improvement.
Working groups for innovative methods development.
Key Requirements :
Doctorate (PhD, ScD, or DrPH) degree from an accredited graduate department of Epidemiology or MD/PharmD /DVM degree with graduate training in Epidemiology or other public health.
A minimum of 10 years of experience in clinical and/or epidemiological research in industry (or equivalent experience in academic setting). Minimum 2 years managing post-marketing safety studies.
In depth knowledge of pharmacoepidemiology methods and RWD sources.
Capability to clearly communicate complex epidemiologic issues to both the scientific community and the general public.
Written and verbal communication proficiency in English, including the presentation of data.
Demonstrated ability to formulate investigational plan and capability to work in crisis situations.
Strategic thinking, business acumen, judgement, interpersonal relationships, personal leadership, drive, and learning agility.
Good understanding in statistics or biostatistics.
Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.
Thank you in advance for your interest.
Only those candidates selected for interviews will be contacted.
Sanofi, Empowering Life
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.