Sanofi Group Pharmacoepidemiologist, Director in Bridgewater, New Jersey
The primary role of a Pharmacoepidemiologist is to provide pharmacoepidemiology support to marketed and investigational products. More specifically, a Pharmacoepidemiologist designs and leads implementation of pharmacoepidemiological studies, and provides pharmacoepidemiological support to GPV (GSO etc) and to other functions within the
In depth knowledge of pharmacoepidemiology methods and data 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.
Teamwork, excellent interpersonal skills and proven time management skills.
PhD degree or Science degree from an accredited graduate department of epidemiology or MD degree/pharmD degree/DVM degree with graduate training in Epidemiology or other public health.
At least 7 years of relevant experience in epidemiological research post education
Duties and Responsibilities:
Pharmacoepidemiological studies and observational post-authorization safety studies (PASS)
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, regulatory, statistician, clinical operations, affiliates)
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 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)
Benefit-Risk Analysis: advise on and conduct quantitative B/R methodology and analysis
Management of pharmacoepidemiological data
- Identify and determine efficient data collection approaches and data sources relevant for the questions being investigated
Be a point of contact and expert for pharmacoepidemiological support in the company notably for Global Safety Officer, PV scientist, Risk Management Expert and Signal Management Expert
- for other functions such as Global Medical Affairs, CSU, Regulatory Affairs and HEOR
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
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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.
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.
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