FDA Drug Safety & Risk Evaluation Fellowship
*Applications will be reviewed on a rolling-basis.
APPLY THROUGH EXTERNAL LINK. RESUME MUST BE SUBMITTED WITH APPLICATION.
A research opportunity is available in the Office of Surveillance and Epidemiology (OSE) / Office of Medication Error Prevention and Risk Management (OMEPRM), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
This project will research scientific methods related to Risk Evaluation and Mitigation Strategies (REMS) implementation and evaluation for marketed drug products to advance regulatory decision making. The participant will learn about how FDA and regulated industry may improve the quality and effectiveness of REMS programs while minimizing program related burden and access barriers.
The participant's research will focus on addressing REMS related issues associated with currently marketed drug products. Under the guidance of a mentor, the participant may complete a research project related to one or more of the following:
- Evidence-based tools and methods to conduct evaluations of REMS programs
- Quality and effectiveness of REMS programs while minimizing program-related burden and access barriers
- Impact of REMS interventions on patients and healthcare providers’ knowledge, attitudes, and behaviors
- The overall science of REMS assessments for broader adoption within the healthcare field
This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The initial appointment is for one year, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. The appointment is full-time at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
Qualifications
The qualified candidate should be currently pursuing or have received a bachelor's or master's degree in one of the relevant fields. Degree must have been received within five years of the appointment start date.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2020-0541) in your email.