Careers

Description:

The Epidemiology Scientist Contractor, with an option after one year to become a permanent hire, will partner with internal and external stakeholders on the design and conduct of epidemiologic research to inform clinical development programs and to support regulatory submissions to the FDA, EMA and other agencies globally. The role will involve internal and external collaborations in conceptualizing and proposing epidemiologic studies, and in writing and reviewing protocols, reports, and presentations. Studies will be communicated in writing and in presentations to internal stakeholders, regulatory authorities, medical professionals and others. The incumbent will also develop and adopt innovative pharmacoepidemiologic methodologies and contribute thought leadership internally and externally regarding Pfizer’s understanding of disease epidemiology/ pharmacoepidemiology to support decision-making across portfolios.

 Specifically, the contractor will support the Internal medicine, rare disease and emerging markets therapeutic area epidemiology activities. GME colleagues are located in New York and Collegeville, PA and but Pfizer is flexible regarding remote work for the right candidate.

Role Responsibilities
Propose and produce GME deliverables for development and product/asset teams, including:
- Background safety and effectiveness epidemiology studies and disease natural history studies.
- Indicated population cohorts for external control arms and regulatory submission.
-Post-approval effectiveness studies
- Feasibility assessments and identification of fit-for-purpose data for observational research
- Other epidemiology studies (e.g., special subpopulations, new indications)
- Critical assessment and review of epidemiological data and literature
- Design and implement primary or secondary data collection or hybrid design pharmacoepidemiologic studies intended to quantify benefits and/or risks potentially associated with Pfizer products
-Participate in GME peer review of study protocols and reports
- Support multiple product teams on epidemiology related issues
- Work collaboratively with key stakeholders internally (such as Clinical, Medical, Regulatory, Outcomes Research, and Data Scientists) and externally (such as academics, regulators, vendors)
- Provide support of and/or attend FDA Advisory Committee meetings and EMA Oral Explanations and other related interactions and negotiations with regulatory agencies on epidemiologic issues as needed