Sanofi Group Pharmacoepidemiologist in Bridgewater, New Jersey

Job Description

The primary role of a GPE 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 within GPE (GSO etc) and to other functions within the

company.

Skills Required

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.

Education:

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.

Relevant experience in epidemiological research.

Duties and Responsibilities:

Pharmacoepidemiological studies and observational post-authorization safety studies (PASS)

Aid in 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 GPE 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

Pharmacoepidemiology Expert

Be a point of contact and expert for pharmacoepidemiological support in the company notably within GPE 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 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

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