An opportunity has arisen for a Director of Pharmacoepidmiology to develop strategy in the designated therapeutic areas. The post holder will work cross functionally, generate epidemiology data to support clinical and regulatory filings. This is a remote based role from within UK.
- Responsibility for pharmacoepidemiology strategy and conduct of regulatory-agency required epidemiologic studies such as PASS, PAES, PMR, DUS. Evaluate the efficiency of REMS and RMMs in support of clinical development, regulatory filings, and post marketing requirements
- As a subject matter authority, contribute to all pharmacoepidemiology activities
- Working closely with Risk Management Leads, Regulatory Affairs and other functions, provide timely epidemiological and risk management support to project and product teams. This includes design, implementation and data analysis of epidemiological studies
- Represent Pharmacoepidemiology on cross-functional teams, including Risk Management Task Force (RMTF), Safety Monitoring Teams (SMT), Clinical Study Teams (including with external partners), Regeneron Safety Oversight Committee, and Independent Data Monitoring Committees
- Proactively lead non-compound specific pharmacoepidemiology activities.
- Provide inputs to IIS studies and other epidemiologic consultation on epidemiologic studies to other departments
- Actively participate in the development and maintenance of relevant SOPs and Working Instructions
- Actively participate in process improvement activities within Global Product Safety
Skills and Requirements
- Must have up-to-date knowledge of US, EU, and international regulatory and pharmacovigilance requirements.
- Function as a subject matter expert on epidemiology for assigned compounds.
- Experience utilising automated healthcare databases (internal and large external databases) to support pharmacoepidemiologic activities. Have significant experience working with external vendors.
- We seek a Doctoral degree in epidemiology or a related field, generally with 5+ years experience.
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