Chelsea Obrochta
Associate Director, Pharmacoepidemiology - Contractor @Regeneron
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WORK HISTORY
Associate Director, Pharmacoepidemiology - Contractor @Regeneron
Manage pharmacoepidemiologic cardiovascular, metabolic, and rare disease real-world evidence (RWE) generation, and conduct regulatory agency required epidemiologic studies (PASS/PMR, PAES, REMS, and DUS) to support clinical development, regulatory filings, and post-marketing commitments. Collaborate closely with Global Patient Safety Leads, Regulatory Affairs, and represent pharmacoepidemiology on cross-functional teams, including Safety Monitoring Teams, Clinical Development Teams (including with external partners), the Regeneron Safety Oversight Committee, and Independent Data Monitoring Committees as needed.• Provide epidemiologic and risk management expertise by designing, implementing, and analyzing epidemiologic studies. Review study proposals from internal and external sources (including administrative claims, electronic medical records (EMRs), surveys, registries, etc.) to evaluate safety/benefit questions, disease natural history, and other relevant epidemiologic data.• Develop Risk Management Plans, Benefit-Risk analyses, post-approval safety studies (not always required by regulatory authorities), signal management, responses to regulatory agency queries, regulatory filings, and safety surveillance.• Identify and assess external data sources (electronic health care databases, patient registries, etc.) for their utility in addressing scientific questions in observational research to support development and life cycle management.• Conduct literature reviews and database queries to support regulatory filings.
EDUCATION
California Polytechnic State University-San Luis Obispo
Bachelor's degree
UC San Diego
PhD in Epidemiology
San Diego State University
Master of Public Health (MPH)
ABOUT CHELSEA OBROCHTA
With over a decade of experience in the Biotech and Pharma industry and a strong…
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