*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of Generic Drugs, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) located in Silver Spring, Maryland.
The CDER Office of Generic Drugs (OGD) is recognized for ensuring that high-quality, affordable generic drugs are available to the American public. The Office of Safety and Clinical Evaluation’s Division of Clinical Safety and Surveillance develops specialized surveillance approaches, adverse event and drug marketing data analyses, and proactive pharmacovigilance screening of generic drugs to address important safety concerns.
Global pharmacovigilance by regulators and pharmaceutical companies increasingly use Real-World Data (RWD), collected and validated across multiple sources after a drug product has been approved. Postmarketing surveillance of generic drugs focuses on data involving generic drug therapeutic inequivalence, quality problems, and issues related to new safety concerns not seen with brand name drugs. The increasing complexity of generic drugs and of generic drug/device combination products brings additional challenges, especially as generic drugs replace brand name drugs over time in the marketplace.
Under the guidance of a mentor, the participant will gain hands-on experience in contributing to the identification of differences in global approaches through research of current generic drug postmarketing safety surveillance methods. The participant will assess the current state of RWD use and help to develop new approaches based on findings. The participant will have an opportunity to attend various internal meetings to learn from established federal specialists, leadership, and other stakeholders.
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.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.