Office Director, Office of Pharmacovigilance and Epidemiology

Duties

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 work groups.

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 work groups addressing clinical, regulatory, postmarket safety, and real-world evidence initiatives.