Epidemiologist monitors and investigates known or suspected sources and transmission of communicable diseases. Collects, analysis, and interprets disease data using appropriate statistical and research methods. Being an Epidemiologist reviews sterilization, disinfection and waste control techniques and recommends changes as needed. Develops and coordinates effective and practical interventions and procedures to control and prevent disease in the community or facility. Additionally, Epidemiologist typically requires a master's degree of microbiology. Typically reports to a manager or head of a unit/department. The Epidemiologist contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature. To be an Epidemiologist typically requires 4 to 7 years of related experience. (Copyright 2024 Salary.com)
This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and compensated under the provisions of this authority.
Additional information on 21st Century Cures Act can be found here:
21st Century Cures Act Information
Introduction
The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices are safe, and effective.
The Center for Drug Evaluation and Research (CDER), is responsible for regulating prescription drugs, including new drugs, generic drugs, biological products and biosimilars as well as over-the-counter drugs (OTC).
The Office of Surveillance and Epidemiology (OSE) within CDER works to detect, assess, prevent, and manage the risks of medications so that they can be relied on to treat disease and improve health. OSE participates in the safety analysis of drugs before they are marketed to patients and consumers and utilize risk assessment tools to identify and assess adverse events and medication errors that did not appear during the drug development process.
This position is in the Divisions of Epidemiology (DEPI I and II). The mission of these divisions are to protect the public using epidemiologic evidence to assess the safety and effectiveness of drugs and biologics and evaluate observational methods and analytical approaches of real-world evidence for drug efficacy.
Duties/Responsibilities
As a Epidemiologist, the incumbent will be responsible for managing pre- and post-approval drug safety and efficacy review, review of epidemiologic submissions from regulated industry, overseeing a portfolio of drug products for which they are responsible for managing post-approval safety and safety signal evaluation. This may include the conduct of literature reviews, and developing and executing safety evaluations using the Sentinel System and other resources. The incumbent will:
How to Apply
Submit resume with cover by June 30 2024 to: DEPI-Applications@FDA.HHS.GOV, with the tracking number OSEDEPIII0624 Candidate resumes may be shared with hiring official within CDER with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”.
Announcement Contact
For questions regarding this Cures position, please contact OSE-PMAS-Admin-Team@FDA.HHS.gov.
The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an equal opportunity employer.