Title 21 Cures Vacancy Announcement

_ Department of Health and Human Services(HHS) _

Food and Drug Administration (FDA)

Center for Biologics Evaluation and Research (CBER)

Office of Biostatistics and Pharmacovigilance (OBPV)

Division of Pharmacovigilance (DPV)

Application Period: Open continuously; applications will be reviewed periodically.

Area of Consideration: The Public. United States Citizenship is required. You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration.

Position: Physician *Multiple selections can be made from this announcement

Series: Physician (0602)

Location(s): White Oak Campus, Silver Spring, MD

Telework Eligible: Yes – as determined by the agency policy. Work Schedule: Full Time

Salary: Starting at $165,000 and is set to commensurate with education and experience.

Travel Requirements: 25% or less

Bargaining Unit: 3591

Title 21 Band: C

Full Performance Band Level: C

Note: Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment, or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc

This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority.

Introduction

The Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe, and that all such products marketed in the United States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated. FDA’s programs are national in scope and effect, and the agency’s activities have a direct and significant impact on multi- billion-dollar industries, in addition to protecting the health and safety of American Consumers. The mission of the Center for Biologics Evaluation and Research (CBER) is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. The Office of Biostatistics and Pharmacovigilance (OBPV) provides comprehensive statistical, pharmacovigilance, and epidemiological evaluation of data submitted to the Center in support of regulatory requirements. OBPV collaborates with other Center components to provide reviews and assessments of regulated biological products. The Office represents the 2 Center within the Food and Drug Administration (FDA), the Public Health Service, the Department, and elsewhere regarding initiatives relating to the statistical and/or epidemiological evaluation of medical products, including the evaluation of product safety. OBPV contributes to the development of regulatory policy in areas relevant to the disciplines of biostatistics, pharmacovigilance, and epidemiology, such as post-marketing surveillance and the design, conduction, and analysis of studies to evaluate medical products. The Office conducts independent research relating to statistical, pharmacovigilance, and epidemiological methods for assessing the efficacy and safety of biological products, and for assuring the quality and consistency of their manufacture. The Division of Pharmacovigilance (DPV) performs pharmacovigilance review to assess the adequacy of the pharmacovigilance plan based on the safety profile data submitted in an original Biological License Application (BLA) or BLA efficacy supplement as part of inter-office, interdisciplinary review teams, and provides recommendations for post-market safety monitoring, post-marketing requirement (PMR) studies, and Risk Evaluation and Mitigation Strategies (REMS) under the Food and Drug Administration Amendment Act (FDAAA). DPV reviews labeling supplements for safety-related label changes. Additionally, the Division reviews the design, evaluates the implementation and clinical safety data from Phase IV post-marketing surveillance studies conducted by regulated industry.

Duties/Responsibilities

The Physician performs pharmacovigilance review to assess the adequacy of the pharmacovigilance plan based on the safety profile data submitted in an original Biological License Application (BLA) or BLA efficacy supplement as part of inter-office, interdisciplinary review teams, and provides recommendations for post-market safety monitoring, post marketing requirement (PMR) studies and Risk Evaluation and Mitigation Strategies (REMS) under the Food and Drug Administration Amendment Act (FDAAA).

Specifically, the Physician will:

• Monitor the post market safety of CBER regulated biological products to inform regulatory decisions.
• Develop and implement systems for the acquisition of data concerning clinical experience and use trends of biological products.
• Develop, maintain, monitor, and analyze national safety surveillance databases of adverse events to biological products, including vaccines, cellular and gene therapies, blood and blood derived products, and tissue allografts.
• Coordinate the Center adverse event reporting systems.
• Review labeling supplements for safety-related label changes as well as the design, evaluating implementation and clinical safety data from Phase IV post-marketing surveillance studies conducted by regulated industry.
• Perform reviews of other safety data analyses submitted by regulated industry.
• Provide advice and guidance regarding those aspects of the application which fall within the incumbent’s area of review expertise.
• Perform other duties as assigned.

Conditions of Employment

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• Employment is subject to the 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.
• 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.
• Financial Disclosure may be required.
• Ethics Clearance may be required.
• Background Investigation/Security Clearance is required. 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.

Qualifications

To be placed into a Cures position, candidates must meet the following criteria:

1. Scientific, Technical, and Professional Fields

2. Qualified and Outstanding Candidates

a. Qualified applies to all candidates for Cures appointments. The FDA OTS will use the basic requirements defined in the below Education/Graduate Training Requirements 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.

In order to qualify for this Title 21 Cures position, the candidate(s) must meet the following required qualifications. Please note: Additional education and experience listed that is not indicated as required is preferable and desired. Candidates who do not meet the “desired” criteria will not be excluded from consideration for this position.

Education/Graduate Training Requirements:

Education: A degree from an accredited program or institution in Doctor of Medicine, Doctor of Osteopathic Medicine, or equivalent.

AND

Graduate Training: In addition to a degree, a candidate must have had at least one year of supervised experience providing direct service in a clinical setting. For purposes of this standard, graduate training programs include only those internship, residency, and fellowship programs that are approved by accrediting bodies recognized within the United States or Canada.

Education Transcripts

SUBMITTING YOUR TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. A transcript is required to verify educational achievement. 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 FDA employee, you are not exempt from transcript requirements.

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 more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation

Desired Education, Experience, or Skills:

An ideal candidate would possess an active medical license in at least one state or U.S. federal jurisdiction.

Security Clearance Requirements

Background Investigation/Security Clearance Requirements: Background Investigation/Security Clearance is required. 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.

Ethics Clearance Requirements

This position may require 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.

Equal Employment Opportunity

The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor. Equal Employment Opportunity (EEO) for federal employees & job applicants

Reasonable Accommodation

Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants should contact the hiring agency 4 directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis. A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits. Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when: An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job. An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace. An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events. You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis.

E-Verify

The Food and Drug Administration participates in the USCIS Electronic Employment Eligibility Verification Program (E-Verify). E-Verify helps employers determine employment eligibility of new hires and the validity of their Social Security numbers.

How to Apply

Please submit electronic resume or curriculum vitae (please be sure to clearly define the number of years using month and year training completed, in addition to describing duties performed during that time period). In describing your experience, please be clear and specific. No assumptions will be made regarding your experience. A copy of your unofficial transcripts (if applicable), copy of your active medical license/s (if applicable), copy of your board certification/s (if applicable), SF50 (if applicable), latest signed PMAP (if applicable), and letter of interest with “CBER/OBPV/DPV Physician Cures Announcement Month/Year (XX/XXXX)” in the subject line to: CBERHumanCapital@fda.hhs.gov and to safia.abulaila@fda.hhs.gov Applications will be reviewed periodically.

Announcement Contact

For questions regarding this Cures position, please contact CBERHumanCapital@fda.hhs.gov.

The Department of Health and Human Services is an equal opportunity employer with a smoke-free environment.

FDA is an equal opportunity employer

Job Type: Full-time

Pay: From $165,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Work Location: In person