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Job Title: FDA Research Opportunity for Systematic Review of Drug Safety Program
Job Number: FDA-CDER-2024-1419
Organization: U.S. Food and Drug Administration (FDA)
Posted: 6/7/2024
Type: Internship
Classification:
Industry:
Number of Openings: 1
Location: Silver Spring,  MD   
Compensation:
Position Description: *Applications will be reviewed on a rolling- basis.

FDA Office and Location: A research opportunity is available in the Office of Surveillance and Epidemiology (OSE), Immediate Office (IO), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.

The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.

Research Project: This project will consist of hands-on experience with excel, risk mitigation and using many databases.

Learning Objectives: Under the guidance of the mentor, the participant will have the opportunity to learn about FDA's drug safety communications, risk mitigation programs, and real-world data in the public health space. Additionally, the participant will develop skills in collecting REMS (risk evaluation and mitigation strategy) data, extracting and organizing drug risk information and elements to assure safe use (ETASU) data. The participant will also have the opportunity to explore whether standardized criteria (e.g., MedDRA) can be linked to REMS drug risks and create a structured risk-benefit of a product.

Appointment Length: The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.

Level of Participation: The appointment is full time or part time (schedule is flexible).

Citizenship Requirements: This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non- U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.

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 participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. 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 Ethics Requirements

If an ORISE Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA. For additional requirements, see FDA Ethics for Nonemployee Scientists.

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.

Qualifications: The qualified candidate should have received a Bachelor's or Master's degree in Health Sciences, or a Doctoral of Pharmacy (PharmD). Degree must have been received within five years of the appointment start date.

Familiarity with Excel and data analysis skills of real-world data. Research skills in gathering and organizing large information. Postgraduate Year 1 Pharmacy Fellows would also be eligible for this opportunity.

Organization Description:

Closing Date: 9/7/2024
Desired Starting Date:
Contact Name: n/a n/a,  FDA Research Opportunity for Systematic Review of Drug Safety Program
Contact Location:

    
Contact Location:
 
      
 
Contact Phone:  
Contact Fax:
Contact Email: ORISE.FDA.CDER@orau.org
Web Address: https://www.zintellect.com/Opportunity/Details/FDA-CDER-2024-1419
How to Apply: The application must be completed through Zintellect.

Additional Information:

Web Site Delete Date: 10/30/2024