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Safety Reviewer

Company: US Food & Drug Administration
Location: Silver Spring
Posted on: December 4, 2019

Job Description:

The FDA’s Office of Surveillance and Epidemiology-Division of Pharmacovigilance (DPV) is recruiting clinical pharmacists for the position of Safety Reviewer The successful candidate will join a multidisciplinary team responsible for the surveillance of adverse events associated with drugs and biological products regulated by the FDA. DPV teams use postmarketing data sources to detect serious adverse events that were not identified during the drug development program. Safety reviewers apply a risk-based approach to evaluate more than 2 million adverse event reports submitted every year to the FDA Adverse Event Reporting System database. In addition to adverse event reports, safety reviewers use a variety of other data sources, surveillance tools, and pharmacologic knowledge to provide scientific and clinical evaluation of safety issues. Safety evaluations may lead to various regulatory actions, such as labeling changes, and public communications to promote the safe use of the product. Responsibilities include:

  • Conduct surveillance of the FDA Adverse Event Reporting System database, medical literature, and other relevant sources in assigned therapeutic areas to identify emerging safety signals.
  • Utilize clinical and scientific judgment to determine the adequacy of clinical documentation, the severity of the adverse event, and the possible causal relationship between specific therapeutic agents and the adverse event.
  • Evaluate the public health impact of the potential or actual risk, the severity of the potential risk, the potential for risk mitigation, and the value and impact of any potential regulatory action.
  • Prepare written and oral deliverables in collaboration with team members that convey relevant scientific data and clinical information to inform regulatory recommendations.

Keywords: US Food & Drug Administration, Silver Spring , Safety Reviewer, Other , Silver Spring, Maryland

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