COMPLETE Pharmacoepidemiology Expert - Toronto, ON

Reference No. R2719414

Position Title: Pharmacoepidemiology Expert

Department: Pharmaco Epidemiology

Location: Toronto, Ontario

Sanofi Vaccines

Sanofi's global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being.

At Sanofi, we chase the miracles of science to improve people’s lives.  We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people. 

Position Summary:

The primary role of a Pharmacoepidemiologist is to provide pharmacoepidemiology expertise and product strategy to marketed and investigational 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 GPV (GSO, PV Scientist and others) and collaborates with other functions (Medical, Clinical, Regulatory, and others) within the company in order to align with product strategy.

Key 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, 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 GP 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.

Pharmacoepidemiology Expert:

•  Be a point of contact and expert for pharmacoepidemiological support in the company notably: (1) within GPV for Global Safety Officer, PV scientist, Risk Management Expert and Signal Management Expert; (2) for other functions such as Global Medical, CSU, RWE, Regulatory Affairs and HEVA.

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 5 years of experience in clinical and/or epidemiological research in industry (or equivalent experience in academic setting).

• 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.

Pursue Progress.

Discover Extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com!

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.

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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.