*Applications will be reviewed on a rolling-basis. Early submissions are encouraged, as a selection could be made before the deadline.
An opportunity is available at the U.S. Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), Division of Veterinary Product Safety (DVPS) located in Rockville, Maryland.
FDA is responsible for protecting and promoting public health through regulation of a wide range of products including human and veterinary medical products, food and tobacco. DVPS is located in the Office of Surveillance and Compliance (OSC). DVPS meets the challenges of CVM’s Mission to protect human and animal health through our post-approval pharmacovigilance program and product safety surveillance efforts. Specifically, we monitor adverse events for approved drugs, pet foods, unapproved drugs, and veterinary devices to identify safety signals and effectiveness issues of concern. For approved drug products, DVPS evaluates adverse event reports to ensure product labeling contains a current accurate safety profile. We also coordinate with FDA District Offices to receive and evaluate product defect reports for the identification of product safety issues and provide pre-market and post-market surveillance of drug product medication errors to CVM review Divisions. DVPS participates in outreach programs to encourage veterinarians to participate in the pharmacovigilance program and to educate veterinarians, animal owners, and the public regarding the medical risks and benefits of veterinary products.
Under the guidance of a mentor, potential training projects for the selected participant include:
- Train to understand and use complex, large relational datasets using the pharmacovigilance databases available in FDA’s Center for Veterinary Medicine. The participant will have the opportunity to use datasets on FDA’s openFDA platform. As a result of this training, the participant will gain the education and knowledge of how to use pharmacovigilance data sets to design visual analytic dashboards that meet the needs of FDA review scientists and the public.
- Contribute to development of visual analytic dashboards in pharmacovigilance software and/or Tableau
- Contribute to development of visual analytic dashboards using application programming interfaces or data available on openFDA
- Collaborate with personnel in the Division of Veterinary Product Safety on the development and/or maintenance of data standards used in relational datasets
Anticipated Appointment Start Date: as soon as a qualified candidate is identified; start date is flexible
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 Rockville, 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.
If you have questions, send an email to ORISE.FDA.OC.firstname.lastname@example.org. Please include the reference code (FDA-CVM-2021-0005) for this opportunity in your email.