FDA Relational Database for Drug Safety Issues Fellowship
A complete application consists of:
- An application
- Transcripts – Click here for detailed information about acceptable transcripts
- A current resume/CV, including academic history, employment history, relevant experiences, and publication list
- One educational or professional recommendation. Your application will be considered incomplete, and will not be reviewed until one recommendation is submitted.
All documents must be in English or include an official English translation.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.
*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of New Drugs/Immediate Office, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
This project will support the establishment of a novel, structured, relational drug safety database comprising information that is currently contained as text within archived PDF documents, and that will link to and leverage information from existing drug databases that contain limited drug safety information. The project will also explore the use of text mining of relevant source documents to facilitate data extraction for and auto-population of the drug safety database.
Under the guidance of a mentor the participant will be trained on finalizing database (Elements; Data entry, quality check, curation procedures; Data entry forms and visualization screens); testing pilot database (Input and analyze data for at least 50 drug products; test linkages to related databases); exploring text mining for data entry (auto-population of data elements); and contributing to identification of necessary next steps to scale up the pilot database and integrate into CDER's IT environment.
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.
Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.
FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency. This agreement covers such topics as the following:
- Non-employee nature of the ORISE appointment;
- Prohibition on ORISE Fellows performing inherently governmental functions;
- Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
- The fact that research materials and laboratory notebooks are the property of the FDA;
- ORISE fellow’s obligation to protect and not to further disclose or use non-public information.
The qualified candidate should be currently pursuing or have received a master's or doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date.
Familiarity with database design and developing relational databases, computer programming, text mining, quantitative statistics, ontologies, standardized nomenclatures, and/or other terminologies is desired.
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