Office Director, Office of Pharmacovigilance and Epidemiology

This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 6, Band G. .

Directs budget planning, resource allocation, and fiscal oversight for office programs. Reviews funding and staffing needs, recommends budget actions, and ensures efficient, cost-effective operations aligned with organizational priorities.

Serves as senior advisor on epidemiology, drug safety, and population health. Develops policy, resolves complex issues, and advises FDA leadership and external partners on regulatory and public health matters.

Directs analysis and implementation of new laws, regulations, and policies affecting office programs. Recommends organizational and operational changes to strengthen the Office's mission and regulatory effectiveness.

Leads high-priority drug safety initiatives and special projects that advance postmarket surveillance, regulatory science, and public health objectives.

Oversees postmarket drug safety programs and multidisciplinary staff conducting safety analyses using FAERS and other data sources to identify, assess, and address safety concerns.

Provides executive leadership for FAERS enhancements and electronic reporting. Advises on regulatory issues, supports compliance activities, and represents OSE on key pharmacovigilance and labeling workgroups.

Reviews epidemiologic study designs, protocols, reports, and datasets submitted by industry to ensure scientific rigor and support evaluation of postmarket drug safety.

Oversees review of adverse event reports and collaborates with CDER offices to evaluate marketed drug safety and recommend appropriate regulatory actions.

Partners with OSE leadership to develop strategic plans, allocate resources, and guide decisions affecting office programs, priorities, and operations.

Represents OSE with Congress, federal agencies, industry, professional organizations, and other stakeholders. Directs preparation of responses on Office programs, policies, and activities.

Directs communication, research, and management of drug safety risks. Coordinates with FDA offices to provide timely safety information to healthcare professionals and the public.

Represents OSE on CDER workgroups addressing clinical, regulatory, postmarket safety, and real-world evidence initiatives.

Ethics Clearance Requirements This position requires financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For more information, please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.