FDA Drug Safety: Postmarketing Requirements (PMR) Fellowship
*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of New Drugs, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
The FDA approves drugs based on evidence that the drug is both effective and safe for use if prescribed according to its labeling. However, since the premarket clinical trials may not always fully characterize the safety risks, the FDA can require a drug sponsor to conduct a postmarketing study/trial to obtain more information about a serious safety risk. This is known as a postmarketing requirement (PMR). The objective of this project is to conduct a comprehensive, descriptive analysis of PMR studies/trials and its associated regulatory actions to provide a better understanding of FDA's use of PMRs and postmarket evaluation of safety risks.
Under the guidance of a mentor, the participant will learn about FDA's use of PMRs in the product development process and postmarket identification and evaluation of safety risks. The participant will also gain knowledge about drug safety studies and CDER's regulatory process.
Qualifications
The qualified candidate should be currently pursuing or have received a master's or doctoral degree in one of the relevant fields, preferably related to pharmacy and medicine/medicinal sciences. Degree must have been received within five years of the appointment start date. Candidates who are currently pursuing their degree should be close to completing the degree.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2020-0527) in your email.