Temp - Pharmacoepidemiologist
SUMMARY/POSITION OBJECTIVE: Briefly describe the general nature and purpose of the job (2-3 sentences)
The Pharmacoepidemiologist will be responsible for managing pharmacoepidemiologic Inflammation and Immunology projects and activities in support of marketed and/or development compounds commensurate with experience/ skill, in accordance with global regulations and Regeneron SOPs and working practices. The candidate should be knowledgeable in the latest epidemiologic methods and resources to be able to be responsive within cross functional teams and to guide decision making where needed.
Under supervision of the Pharmacoepidemiology Therapeutic Area (TA) lead for Inflammation and Immunology:
Manage the generation of real-world evidence (RWE) in support of the regulatory queries and submissions, design and conduct of regulatory required epidemiologic studies such as PASS/PMR, PAES, REMS, DUS, and other post-marketing commitments for assigned marketed/development compound(s) or TAs Actively contribute to other pharmacoepidemiologic activities for assigned marketed/development compound(s) or TAs, including but not limited to: (Development) Risk Management Plans, Benefit-Risk analyses, post-approval safety studies that may not be required by a regulatory authority, signal management, responses to regulatory agency queries, regulatory filings, safety surveillance and others. Work closely with Global Patient Safety Leads, Regulatory Affairs, and other internal stakeholders, provide timely epidemiologic and risk management support to project and product teams including design, implementation and analysis of epidemiologic studies, review of study proposals from internal and external sources, (administrative claims/EMR/surveys/registries etc) to evaluate safety/benefit questions, disease natural history, and other appropriate epidemiologic data in support of clinical development and regulatory filings Help with identification and assessment of external data sources (electronic health care databases, patient registries, others) for their utility in addressing scientific questions in observational Inflammation and Immunology research to support development and life cycle management Manage and/or conduct non-compound specific pharmacoepidemiology activities (ex. literature review and database queries in support of regulatory fillings) Represent Pharmacoepidemiology on cross-functional teams, including Safety Monitoring Teams, Clinical Development Teams (including with external partners), Regeneron Safety Oversight Committee, and Independent Data Monitoring Committees as needed
- Broad understanding of the limitations and strength of real-world data and demonstrated expertise on the design and conduct of epidemiologic studies
- Experience in Inflammation and Immunology is a plus
- Up-to-date knowledge of US and international regulatory guidances (e.g., pharmacovigilance, RWE, good epidemiology practices) and ability to apply this knowledge to pharmacoepidemiology activities throughout the product life-cycle and knowledge of the U.S. and ex-U.S healthcare systems and prior experience utilizing automated healthcare databases to support pharmacoepidemiologic activities is desirable
- Strong oral and written communication skills an ability to summarize and present the results of epidemiological studies to different stakeholders with different backgrounds
- Ability to work in a highly interactive and cross-functional environment, as well as work independently with limited supervision.
Minimal educational requirements:
- Doctoral degree in epidemiology or a related field
- MD, plus other post-graduate degree in epidemiology or a related field (e.g. MPH, MSc)
- Recent PhD graduates in epidemiology or a related field
- Other post-graduate degree in epidemiology or a related field (e.g. MPH, MSc), generally with 2+ years of relevant experience in Pharmacoepidemiology