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

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• 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

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Conditions of employment

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.

Qualifications

In order to qualify for the Office Director, Office of Pharmacovigilance and Epidemiology position which falls under the 0601 occupational Series, you must meet the following requirements by 11:59 pm EST on 08/13/2026:

The candidate must meet the following qualifications for this Title 21 position:

1. Scientific, Technical, and/or Professional Fields
2. Qualified and Outstanding Candidates

a. Qualified applies to all candidates for Cures appointments. The FDA OTS will use the technical qualifications defined below as a baseline for comparing experience levels and other candidate attributes for relevant positions

b, Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both.

Technical Qualifications: Candidates do not need to provide narrative responses. However, the technical qualifications must be reflected within the candidate's two-page resume.

• At least 3 years experience in managing a multi-disciplinary professional staff that is responsible for developing and using epidemiologic and other evidence to assess the effectiveness and safety of human drug and therapeutic biologic products and making recommendations on actions to improve patient safety and protect and promote the public health.
• Demonstrated ability in providing authoritative and professional expertise in health sciences, including epidemiology, drug safety and population health issues related to the regulation of human drug and therapeutic biological products to internal and external stakeholders.
• Demonstrated ability in providing critical reviews in the study design and methods of epidemiologic and other study protocols relevant to the assessment of post-marketing drug safety submitted by the pharmaceutical industry.

Desired Qualifications:

• Experience applying the Food and Drug Administration Amendments Act, regulations, policies, and procedures related to the regulation and evaluation of drugs and biologic products.

This position is designated as an SES Equivalent position and is covered under the FDA Title 21 Executive Performance Management System and identified as a public filing position for ethics purposes. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.

Supervisory Responsibilities:

• The incumbent provides occupational specific technical and administrative direction 25 percent or more of the time to three or more subordinate employees performing the work and functions of the organization.
• Obtains resources and identifies strategic objectives for the organization.
• Defines jobs, selects employees, and assigns work; defines technical work requirements and milestones; evaluates the organization and employee accomplishments by accepting or rejecting work products; and presents and defends organization and employees work to senior management and other offices.
• Recommends employee promotions and recognition; approves leave; implements performance modifications and takes corrective actions as appropriate.
• Provides employees with resources and information that ensure a safe and healthy work environment.

Conditions of Employment:

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• The candidate selected for this position will serve under a career or career-conditional appointment within the competitive service.
• Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
• FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
• Males born after December 31, 1959, must be registered with the Selective Service. Please go to http://www.sss.gov for more information.
• Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
• Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
• All applicants tentatively selected for this position will be required to submit to urinalysis to screen for illegal drug use prior to appointment and be subject to random, reasonable suspicion, and post-accident drug testing upon hiring.
• Appointment to the position will be contingent upon a negative applicant drug test result.
• Probationary periods are required for new employees appointed to competitive service positions for the first time; or reinstated employees who return after a break in service of 30-days or more and who have not completed a probationary period.
• Pre-employment physical required: No
• Drug testing required: No
• License required: No
• Mobility agreement required: No
• Immunization required: No
• Bargaining Unit: No
• Telework eligible position: Telework is at the discretion of the supervisor.

Applicants must meet all qualification requirements by the closing date of this announcement.

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:

1. National Association of Credential Evaluation Services (NACES)
2. Association of International Credentials Evaluators (AICE)

Credential evaluations are not free, and applica