The Research/OPPE Pharmacy Program Manager is responsible for the review of research protocols and the receipt, storage, security, labeling, dispensing, and disposition of all investigational drugs, and responsible for the completion and tracking of the requirements for the Risk Evaluation and Mitigation Strategy (REMS) medications. The Research/OPPE Pharmacy Program Manager will also coordinate the FPPE/OPPE pharmacy program.

Duties

Functions of the Position: The Clinical Pharmacy Specialist (CPS) serves as a mid-level provider with prescribing privileges as outlined in the individual's Scope of Practice for Clinical Pharmacy Specialist (CPS). The CPS functions at the highest level of clinical pharmacy practice to provide evidence-based pharmaceutical care to patients. This includes, but is not limited to, the following: designing, implementing, assessing, monitoring and documenting therapeutic plans utilizing best evidence, most effective, least toxic and most economical medication treatments; helping achieve positive patient centric outcomes through direct and indirect interactions with patients, providers, and interdisciplinary teams in assigned areas; performing physical assessments; and ordering laboratory and other tests to help determine efficacy and toxicity of medication therapy. The Research/OPPE Pharmacy Program Manager in conjunction with the Chief, Pharmacy Service is responsible for the receipt, storage, security, labeling, dispensing, and disposition of all investigational drugs and supplies used in clinical investigations, and for ensuring that there is adequate pharmacy staffing and resources to safely conduct investigational drug studies in compliance with all rules and regulations. Incumbent will be responsible for managing and assisting in development of provider and patient resources. Incumbent will exercise initiative and collaborate effectively with clinical and administrative pharmacy staff to promote and support quality patient care. The Research/OPPE Pharmacy Program Manager will coordinate the FPPE/OPPE pharmacy program in conjunction with the Associate Chief Pharmacy, Clinical Services. In addition, the Research/OPPE Pharmacy Program Manager will coordinate the completion and tracking of the requirements for the Risk Evaluation and Mitigation Strategy (REMS) medications. Major Duties and Responsibilities: A. Procurement Manager 1. Coordinates, monitors, develops and evaluates the activities of the Investigational Pharmacy. 2. Maintains drug accountability logs and all required forms. The investigational pharmacist maintains records for the receipt, storage, and dispensing of all study medications. 3. Responsible for ensuring ongoing compliance with medication management standards set forth by JC. FDA, and Office of the Inspector General (0IG). 4. Maintains expert understanding of regulatory and quality standards for their program area. 5. Within established organizational and departmental policies and procedures, participates in various medication use safety and improvement plans. B. Clinical 1. Analyzes research protocols for potential adverse drug reactions, drug interactions, or contraindications that may have a direct impact on the safety and welfare of study participants or contribute to the need for utilization of health care resources. 2. Responsible for maintaining a computerized listing of all active drug studies that can be efficiently and reliably reviewed to notify investigators of Pharmacy Benefits Management (PBM) Drug Safety Bulletins and National PBM Communication Drug Safety Alerts related to their research. 3. Monitors drug therapy regimens, including routine analysis of patient drug therapy through chart reviews and audits of medical records and communicates these analyses with other health care providers responsible for patient care. When required, educates nurse coordinators and subjects on their drug therapy concerning compliance, proper administration, signs of toxicity, adverse effects, and interactions with other medications. C. Administrative 1. Works with administration and staff to identify and implement new programs. 2. Develops and updates policies and procedures defining operational requirements of the section. 3. Serves as the pharmacy representative on various medical center committees (i.e.: P&T, Medication Management, etc.) 4. Assists administrative staff in preparation of TJC, 0IG, ASHP, and other governing bodies for evaluations. D. Educate 1. Plans, develops, implements, coordinates and evaluates regular formal and informal training and education of alternate investigational pharmacists, investigators and clinical research coordinators. 2. Provides input and assistance to pharmacy administration on issues related to areas of practice and expertise. 3. Serves as a preceptor for pharmacy students and residents. 4. The incumbent is responsible for maintaining his/her professional competency by keeping up with information on new drugs, new drug therapies, innovations in pharmacy practice, and integrating this information in his/her daily practice. Work Schedule: Monday - Friday, 7:30am - 4:00pm. Telework: Not Available. Virtual: This is not a virtual position. Functional Statement #: Licensed Pharmacist(Facility Program Manager) - Research/OPPE/PD000000 Financial Disclosure Report: Not required

Requirements

Qualifications

Applicants pending the completion of educational or certification/licensure requirements may be referred and tentatively selected but may not be hired until all requirements are met. To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 08/30/2024. Basic Requirements: United States Citizenship: Non-citizens may only be appointed when it is not possible to recruit qualified citizens in accordance with VA Policy. Language: Must be proficient in spoken and written English Education Graduate of an Accreditation Council for Pharmacy Education (ACPE) accredited College or School of Pharmacy with a baccalaureate degree in pharmacy (BS Pharmacy) and/or a Doctor of Pharmacy (Pharm.D.) degree. Graduates of foreign pharmacy degree programs meet the educational requirement if the graduate is able to provide proof of achieving the Foreign Pharmacy Graduate Examination Commission (FPGEC) Certification, which includes passing the Foreign Pharmacy Graduate Equivalency Examination (FPGEE) and the Test of English as a Foreign Language Internet-Based Test (TOEFL iBT). Licensure. Full, current and unrestricted license to practice pharmacy in a State, Territory, Commonwealth of the United States (i.e., Puerto Rico), or the District of Columbia. The pharmacist must maintain current registration if this is a requirement for maintaining full, current, and unrestricted licensure. GS-13 GRADE EXPERIENCE Experience. In addition to the GS-12 requirements, must have 1 year of experience equivalent to the next lower grade level. Preferred Experience: In addition to basic Qualification Standard: completion of ASHP-accredited PGY-1 Pharmacy Practice Residency and/or PGY-2 Specialty Pharmacy Residency (in an applicable specialty) or equivalent experience in the major duties for at least 3 years. Assignment. Candidates at this grade level are to be in one of the assignments listed below. For all assignments above the full performance level, the higher level duties must consist of significant scope, administrative independence, complexity (difficulty) and range of variety as described in this standard at the specified grade level and be performed by the incumbent at least 25% of the time. Facility Program Manager. Manages all aspects of a distinct program to include policy development, quality resources and specialty functions unique to the program to optimize cost effectiveness (budget) and patient outcomes. Coordinates a single program area of a complex pharmacy operation, or multiple program areas within a facility to develop, organize, manage, and control complex pharmacy programs. Develops, organizes, coordinates and manages single or multiple program areas within the medical facility; this may include a single program area at multiple facilities. The Program Manager title is reserved for those individuals who have one or more of the following: supervisory responsibilities for various sections within Pharmacy Service; a complex program requiring coordination of multiple locations such as medical center care facilities, Community Based Outpatient Clinics (CBOCs), rural health, telemedicine, etc; specialized areas of a complex nature such as nuclear pharmacy, quality assurance, pharmacy informatics, clinical applications coordinator, Home Based Primary Care, pharmacoeconomist or liaison pharmacist duties requiring the coordination of processes with other medical facilities or VISNs. Pharmacists assigned to this position must demonstrate the KSAs identified in subparagraph 3b(3)(b)1 above. 1. Ability to communicate orally and in writing to persuade and influence clinical and management decisions. 2. Expert understanding of regulatory and quality standards for their program area. 3. Ability to solve problems, coordinate and organize responsibilities to maximize outcomes in their program area or area of clinical expertise. 4. Expert knowledge of a specialized area of clinical pharmacy practice or specialty area of pharmacy. 5. Advanced skill in monitoring and assessing the outcome of drug therapies, including physical assessment and interpretation of laboratory and other diagnostic parameters. References: VA Handbook, 5005, Part II, Appendix G15, Licensed Pharmacist Qualification Standard Physical Requirements: Employees are typically expected to work forty hours per week. This may include evenings and weekends functioning as a CPS. Principle duties require repetitive use of hands and fingers (e.g., handling prescriptions, use of a computer keyboard, etc.). May require lifting and carrying light loads (up to 25lbs.), including boxes, packages, and equipment, stooping or kneeling (e.g., to pick up items from the floor, remove and replace items on lower shelves, and to file documents in lower file drawers, etc.); sitting, walking, or standing for long periods of time (4-8 hours). Normal ranges of hearing and vision are required to perform work and communicate effectively; must have the visual ability to distinguish between basic colors and shades of color. An ability to perform tasks requiring rapid mental and muscular coordination functions simultaneously is necessary. Employees must be physically capable of operating various types of equipment used on the job. Employees may be asked to work voluntary overtime within different pharmacy locations during periods of extreme staffing shortages. If there are no volunteers, reverse seniority will be utilized to work mandatory overtime within their respective clinical areas or as coverage for fellow pharmacy specialists. The full performance level of this vacancy is GS-12.

Education

IMPORTANT: A transcript must be submitted with your application if you are basing all or part of your qualifications on education.

Note: Only education or degrees recognized by the U.S. Department of Education from accredited colleges, universities, schools, or institutions may be used to qualify for Federal employment. You can verify your education here: http://ope.ed.gov/accreditation/. If you are using foreign education to meet qualification requirements, you must send a Certificate of Foreign Equivalency with your transcript in order to receive credit for that education. For further information, visit: http://www.ed.gov/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html.

Contacts

• Address Captain James A Lovell Federal Health Care Center 3001 Green Bay Road North Chicago, IL 60064 US
• Name: Doug Madel
• Phone: 608-667-6533
• Email: [email protected]