The U.S. Food and Drug Administration (FDA) Office of Surveillance and Epidemiology, Division of Pharmacovigilance (DPV) is recruiting internal medicine, critical care, and oncology clinical pharmacists for the position of Safety Evaluator. Safety Evaluators have the unique opportunity to influence patient care on a population level, not found in typical pharmacy practice settings. 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 and 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 Evaluators use a variety of other data sources, surveillance tools, and clinical knowledge to provide scientific evaluation of safety issues. Safety evaluations may lead to various regulatory actions, such as labeling changes and public communications to promote safe use of the product.
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.
Collaborate as a member of a multidisciplinary team of physicians, epidemiologists, and other scientific professionals.
PharmD, current licensure in any U.S. state, and completion of an ASHP accredited PGY1 residency are required credentials. Preference is given to those candidates with completion of a PGY2 residency in internal medicine, critical care, or oncology; completion of a Master of Public Health degree; or evidence of scholarship, such as authorship in peer-reviewed journals.
Safety reviewers in FDA's Division of Pharmacovigilance detect safety signals and assess safety-related issues for all marketed drug and therapeutic biologic products. They use a variety of surveillance tools including adverse event report data, published scientific literature, and preclinical, clinical, and pharmacologic knowledge of the products to provide scientific and clinical evaluation that leads to various regulatory actions and communications for safe use of the marketed products.