Responsible for pharmacoepidemiology strategy in the designated therapeutic areas. Drive cross-functional project teams and epidemiology activities such as regulatory agency-required epidemiologic studies. Generate epidemiology data to support clinical development and regulatory filings. Provide consultation as an in-house subject matter authority in epidemiology to other departments.
In this role, a typical day might include the following:
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.
This role might be for you if:
Do you 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 utilizing 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.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.#LI-EG1