Summary
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 4, Band G.
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 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.
Requirements
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.
Education
Education Requirements: Bachelor's or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the position. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education(external link) at the time the degree was obtained. https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0600/general-medical-and-healthcare-series-0601/ Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements. TRANSCRIPTS (Required): Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education. If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements. Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access. Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit the U.S. Department of Education website for Foreign Education Evaluation. To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery. Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded. Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below: National Association of Credential Evaluation Services (NACES) Association of International Credentials Evaluators (AICE) Credential evaluations are not free, and applicants are responsible for the cost of the selected service. For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.