Manager, Pharmacoepidemiology-Contractor

Location
Tarrytown, New York, United States of America
Posted
Jul 23, 2021
Ref
R1178
Required Education
Bachelors Degree
Position Type
Full time
The Pharmacoepidemiologist will be responsible for managing pharmacoepidemiologic Cardiovascular, Metabolism, and Rare disease 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.

Essential Functions required for the job. List both technical and managerial requirements if applicable.

Responsibilities:

Under supervision of the Pharmacoepidemiology Therapeutic Area (TA) lead for Cardiovascular, Metabolism, and Rare disease:

1. 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

2. 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.

3. 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

4. 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 Cardiovascular, Metabolism, and Rare disease research to support development and life cycle management

5. Manage and/or conduct non-compound specific pharmacoepidemiology activities (ex. literature review and database queries in support of regulatory fillings)

6. 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