This position is being filled through the Direct Hire Authority for this occupation and is open to all US Citizens. All applicants who meet the basic qualification requirements will be forwarded to the Selecting Official for consideration. Traditional rating and ranking of applications does not apply. Applications received as a result of job fairs, recruitment events, and emergency hiring mechanisms in support of this hiring initiative will also be accepted during the duration of the direct-hire authority.

Positions are located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA) in Montgomery County, MD, and may be filled in the following Centers: These positions are located throughout the FDA Centers:

Center for Biologics & Evaluation Research (CBER) - Regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. To ensure the safety, purity, potency, and effectiveness of biological products.

Center for Drug Evaluation & Research (CDER) - Provide regulatory oversight for investigational studies during drug development and making decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products.

Center for Devices and Radiological Health (CDRH) - Facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

Center for Food Safety and Applied Nutrition (CFSAN) - Responsible for the safety of the nation's domestically produced and imported foods, cosmetics, drugs, biologics, medical devices, and radiological products.

Center for Tobacco Products (CTP) - Set performance standards review premarket applications for new and modified risk tobacco products, requiring new warning labels, and establishing and enforcing advertising and promotion restrictions.

Office of Regulatory Affairs (ORA) - Inspects regulated products and manufacturers, conducts sample analyses of regulated products and reviews imported products offered for entry into the United States.

National Center for Toxicological Research (NCTR) - Provides the field offices with coordinated direction, assistance, and management for investigational activities in international arenas.

Center for Veterinary Medicine (CVM) - Conducts research that helps FDA ensure the safety of animal drugs, food for animals, and food products made from animals; and monitors the safety and effectiveness of animal drugs on the market.

As a Pharmacist you will:

• Review, evaluate, interpret, analyze, and abstract pertinent adverse drug reaction reports in the Adverse Events Reports Systems (AERS);
• Utilize the medical-scientific judgment in determining the adequacy of clinical documentation, the severity of the adverse reaction, and the possible causal relationship between specific therapeutic agents and the adverse reaction;
• Prepare summaries describing clinical assessment of adverse reaction analyses;
• Contribute to the development and improvement of procedures for post-marketing surveillance and the processing and evaluation adverse drug product reaction reports;
• Keep abreast of new developments in drug products and their applications in order to anticipate possible safety and reporting problems.

Conditions of employment

• U.S. Citizneship is required for federal employment.
• A 1-year probationary period may be required for some positions.
• Applicants must be able to distinguish basic colors.
• Transcripts required.
• A valid license must be submitted at time of application to be considered.
• Background investigation is required

Conditions of Employment:

• Security and Background Requirements: Appointment will be subject to the applicant's successful completion of a background security investigation. Failure to successfully meet these requirements may be grounds for appropriate personnel action. If hired, a background security reinvestigation or supplemental investigation may be required at a later time. Applicants are also advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-consideration, non-selection or appropriate disciplinary action.
• E-Verify: If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "E-Verify" System. Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system. The U.S. Department of Health and Human Services is an E-Verify Participant.
• Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.
• License required: Except for research positions that do not entail patient care, all applicants must be licensed to practice pharmacy in the State, territory of the United States, or the District of Columbia.
• Bargaining Unit Position: May vary by center
• Travel, transportation, and relocation expenses: may be paid.
• Recruitment Bonus may be authorized: No
• Financial disclosure statement: may be required.
• One-year probationary period: may be required.
• Drug Screening Required: No

Qualifications

In order to qualify for this position, applicants must possess the basic education requirement, medical requirement, licensure and specialized experience as defined below:

Basic Education Requirement: Four-year bachelor's degree in pharmacy recognized by the American Council on Pharmaceutical Education.

AND

Licensure: All applicants must be licensed to practice pharmacy in a State, territory of the United States, or the District of Columbia.

AND

Medical Requirement: Applicants must be able to distinguish basic colors.

Additional Qualification Requirements for the GS-13: Applicants must possess one have one (1) year of specialized professional pharmacy experience equivalent to at least the GS -12 grade level in the Federal service which has equipped me with the specific knowledge, skills and abilities to perform successfully in this position may involve, but not limited to include: work involved in compounding, formulating preparing, selecting, and dispensing prescriptions. Preserving drugs medicines, chemicals and maintaining records of medication. Advising on drug therapy and usage in a hospital, clinic or a facility in the pharmaceutical health industry.

How you will be evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

Once the job opportunity announcement closes (at 11:59 pm ET on 12/31/17), a review of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for Federal employment, and then whether or not you are qualified for this particular position. If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible or your score may be adjusted to more accurately reflect your skills and abilities.

Please follow all instructions carefully. Errors or omissions may affect your eligibility.