Office Director, Office of Pharmacovigilance and Epidemiology (Silver Spring)

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 6, Band G.

Requirements

In order to qualify for the Office Director, Office of Pharmacovigilance and Epidemiology position which falls under the 0602 occupational Series, you must meet the following requirements by 11:59 pm EST on 08/13/2026.

Qualifications

• Scientific, Technical, and/or Professional Fields Qualified and Outstanding Candidates:
• a) Qualified applies to all candidates for Cures appointments.
• 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.

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.
• Direct Deposit: federal salary payments must be electronically deposited.
• FDA participates in e‑Verify: all new hires must complete the I‑9 form; this information will be processed through e‑Verify to determine employment eligibility.
• Background Investigation Requirement: all employees must pass a security investigation.
• Certification of Accuracy: all information concerning eligibility and qualification is subject to investigation and verification.
• 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.
• No drug testing required.
• No license required.
• No mobility agreement required.
• No immunization required.
• No bargaining unit.
• Telework eligible position: telework is at the discretion of the supervisor.
• Ethics pre‑clearance/OGE‑278 required: this position is subject to FDA's prohibited financial interest regulation and may require divestment of certain financial interests.
• Financial disclosure statement required: will be subject to FDA's prohibited financial interest regulation.
• Employment is subject to successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job‑related requirement before or after appointment.
• Applicants must meet all qualification requirements by the closing date of this announcement.

Location

The position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), CDER, OSE, OPE.