The Divisions of Epidemiology within CDER's Office of Surveillance and Epidemiology is recruiting for Epidemiologists at our beautiful White Oak campus in Silver Spring, Maryland. At CDER, you can make a difference in protecting the health of the American people. CDER serves as the consumer watchdog of America’s healthcare system by making sure that safe and effective drugs are available to improve the health of consumers and that prescription and over-the-counter drugs, both brand and generic, work correctly and that the health benefits outweigh known risks.
The divisions are responsible for the review and analysis of epidemiologic study protocols and reports of completed studies submitted by the pharmaceutical industry including review of reports in the literature that are related to the post marketing safety of drugs. In addition, the Division is responsible for designing and conducting observational studies of drug safety in Sentinel and other data systems, the development and assessment of methodologies and best practices for scientifically-sound observational studies, active and passive surveillance systems and for incorporating data, when appropriate, into the review of the post marketing safety of drugs. Furthermore, the Division is responsible for the review and analysis of drug utilization information to determine the frequency and usage patterns of drug products and monitor changes over time.
The divisions are actively working to combat the opioid public health crisis by evaluating data on the abuse and misuse of medicines, leading analyses examining the abuse of medicines using a variety of data resources, providing critical evaluation and review of Postmarketing observational studies conducted by industry, and providing comprehensive reviews of the literature. Epidemiologists synthesize the evidence from multiple data streams to develop regulatory approaches to help address the crisis and protect the public health.
Epidemiologists within the Divisions serve as experts in their subject area(s) to plan and conduct multiple scientific reviews and research studies focused on the safety of drugs and therapeutic biologic products. Studies are designed for the purpose of identifying and characterizing the risks associated with the use of medicines. The incumbent may participate, coordinate, or lead a multidisciplinary team and serve as principal investigator in research studies.
Interested applicants should also send a CV using the "Apply Now" option. Applicants with a PhD in epidemiology, or an MPH and a health sciences degree (MD, RPh, RN) are preferred. Experience is pharmacoepidemiology is desirable but not required.
Basic Requirement: Bachelor's or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education (external link) at the time the degree was obtained. Unofficial transcripts will be accepted in the application package. Official transcripts will be required prior to appointment to this position).
Minimum Qualification: You must have one year of specialized experience, equivalent to the GS-12 in the Federal service to include conducting epidemiologic research of data sources to monitor and evaluate health and medical products safety data; and planning and researching projects pertinent to the assessment of the risks associated with the use of drugs.
Additional requirements are detailed in the posting on USAJobs.gov
Additional Salary Information: GS-13 starting at $96,970, GS-14 starting at $114,590
Internal Number: 1
About United States Food and Drug Administration
FDA is an agency within the Department of Health and Human Services.
The FDA's organization consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods, Global Regulatory Operations and Policy, and Operations.
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.
The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.