FDA Epidemiology Fellowship
*Applications will be reviewed on a rolling-basis.
A research opportunity is currently available at the U.S. Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN), Office of Cosmetics and Colors (OCAC) located in College Park, Maryland.
Under the guidance of a mentor, the participant will assist in the development of the adverse event analysis program in the OCAC. The participant will collaborate with a multidisciplinary staff consisting of chemists, toxicologists, microbiologists, computational toxicologists, physicians, management and other staff members. Throughout the course of this research project, the participant will:
- Be trained in CFSAN’s Adverse Event Reporting System (CAERS) by CAERS personnel in order to learn how to perform searches of the adverse events database, and to become familiar with other reporting systems that CFSAN has purchased. Instruction will include the use of tools for evaluating adverse events information regarding cosmetics and other FDA-related regulated products.
- Learn about the legal framework for cosmetic regulation and the application of epidemiology and other sciences to assessing the safety of cosmetic products and ingredients in a regulatory environment.
- Become acquainted with other FDA adverse event reporting systems and learn about their applications.
- Assist with project within the OCAC CAERS team, as well as on the larger CFSAN adverse events team(s) and relevant Agency teams as appropriate.
- Conduct longitudinal assessments of the adverse events for both products and ingredients, considering a 10 year period, focusing on recurring adverse events and those occurring more frequently.
- Contribute to the development of tools to overcome the innate challenges in the adverse events reporting system for cosmetics, such as the lack of necessary information including product labels and product ingredients in the adverse events reports. In addition, assess ability to use data from the Voluntary Cosmetic Registration Program to help identify ingredients and products.
- Prepare a monthly report of the adverse event findings and recommendations for any subsequent action or need for further collaboration.
- Identify tools to compare adverse events in the US market, with adverse events in other international jurisdictions.
- Help provide scientific support towards the development of any guidances or policies that might be related to adverse events analyses for cosmetic products and ingredients.
- Provide scientific support for the interpretation of adverse events data, as they might relate to safety data, such as in vitro, in vivo and in silico.
- Contribute to the preparation of manuscripts to publish work conducted under the appointment in OCAC and/or presentations for scientific meetings.
Anticipated Appointment Start Date: Summer/Fall 2020
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 College Park, 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.CFSAN@orau.org.