*Applications will be reviewed on a rolling-basis.

A research opportunity is currently available in the Office of Translational Sciences, Immediate Office (OTS – IO) at the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.

The project will focus on extracting drug-adverse event information from free text clinical narratives related to mental health disorders, opioid addiction, and opioid overdose and to characterize the infectious and non-infectious complications reported in opioid overdose patients.

The objective is to enhance a natural language processing and machine learning classifier system to capture information in free text clinical narratives that facilitates drug-adverse event detection; this work aims to harness structured and unstructured EHR data (MIMIC-III and MIMIC-IV databases) for pharmacovigilance; to employ the natural language processing and machine learning system to extract information from free text clinical narratives related to mental health disorders, opioid addiction, and opioid overdose (including intentional overdoses/suicide) and to characterize the infectious and non-infectious complications reported in opioid overdose patients; and to develop a prototype web-based data visualization tool and dashboard to facilitate exploring demographic, administrative, ICD codes, and other structured data in MIMIC-III and MIMIC-IV through tables, charts, and other graphics.

Under the guidance of a mentor the participant will learn to develop a natural language processing and machine learning system to enhance drug-adverse event mining of clinical narratives from electronic health records (EHR) and other free text biomedical resources.

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 (FDA-CDER-2021-0615) in your email.