MAIN FUNCTION:

This position will be responsible for the oversight of regulatory requirements, including policy development and management, within the entity specific pharmacy departments, the system hospitals, and the system ambulatory provider-based billing clinics to ensure compliance as it relates to all regulatory bodies, state and federal law. 

EDUCATION:

Graduation from an ACPE accredited School of Pharmacy with a PharmD or with an advanced degree.

LICENSES:

Must have a current, unrestricted pharmacist license, licensed to practice Pharmacy in the Commonwealth of Pennsylvania and the State of New York. 

EXPERIENCE:

Minimum experience of 3-5 years in a hospital setting as a pharmacist.

Dedicated experience in the area of pharmacy regulatory compliance is preferred.

Must have demonstrated ability to facilitate change and work collaboratively with diverse, multidisciplinary teams.

JOB DESCRIPTION:

Under the direction of the VP, Pharmacy Services, the Pharmacy Clinical Specialist – Regulatory Compliance is responsible for ensuring the delivery of quality pharmacy services by providing leadership, direction, and technical expertise in the planning, development, coordination, implementation, and evaluation of Compliance issues related to regulatory or practice standards. The Pharmacy Compliance Specialist aids in maintaining compliance with a number of government agencies, acts, guidelines and laws. In addition, the Compliance Specialist is responsible for going beyond knowing the laws and regulations and their applicability to workflows and organizational processes. A major responsibility is to facilitate, coordinate or conduct investigations and audits to identify areas of risk, draft a process improvement plan in collaboration with other departments or areas to improve compliance to address the risk, and monitor to ensure the process or program is following best practices and established standards.

This position requires cross-functional collaboration with multiple disciplines to produce quality outcomes related to organizational compliance with regulatory, state and federal standards. It requires an in-depth understanding of clinical practice, in order to develop, achieve and maintain quality practices and outcomes and independent demonstration of initiative, collaboration among all disciplines and accurate assessments of processes. The role requires data collection, analysis, management and presentation. Excellent communication skills is a must.

This position requires coordinating quality services, with Clinical Services, in efforts to integrate, implement, and develop procedures, policies, and protocols. The Pharmacy Compliance Specialists is responsible for facilitating meetings with other hospital departments to assist with analysis, planning and implementation of compliance issues. The Pharmacy Compliance Specialist must comply with current departmental and institutional policies, as well as regulations set aside by regulatory bodies (i.e. The Food and Drug Administration, Drug Enforcement Administration, Department of Health, The Joint Commission, The United States Pharmacopeia and others as applicable). The Pharmacy Compliance Specialist is responsible for attending regular committee meetings as assigned and mandatory staff meetings.

REQUIRED SKILLS/KNOWLEDGE:

Decision Making and Judgment - Professional competence and common sense Equipment - Proficient knowledge of computer applications (i.e MS Word, Excel, PowerPoint, CPOE, E-mail, etc.) Analytic, investigative and decision making skills Ability to work with data and draw inferences from multiple sources and types of information Works independently, with minimal supervision Ability to work collaboratively with other departments and areas Ability to work on multiple projects and assignments Working knowledge of state, federal and healthcare regulations Proven time management skills and attention to detail Ability to work professionally in collaboration with multiple areas, with providers on all levels (excellent interpersonal and professional skills) Self-motivated with a positive attitude when collaborating, training or presenting to others Ability to identify opportunities to improve clinical and administrative processes Ability to continuously validate and verify information needed for decision making or documentation

ESSENTIAL FUNCTIONS/RESPONSIBILITIES:

Ensure the delivery of quality pharmacy services by providing leadership, direction, and technical expertise in the planning, development, coordination, implementation, and evaluation of Compliance issues related to regulatory or practice standards Provides oversight and direction for the ongoing management and regulatory compliance of medication management Coordinates compliance and regulatory functions to ensure that departmental operational activities meet legal requirements and accreditation standards for quality and safety Oversees the ongoing management and adherence to best practices for all medication management processes to include procurement, storing, ordering, preparing, administration, dispensing (as applicable), and monitoring Ensures compliance with government agencies, acts, guidelines, and laws Routinely monitors state and federal regulatory sites for changes, providing updates to leadership/front line teams as appropriate Leads and/or contributes to the development and operationalization of policies, procedures, and job aids to ensure medication management best practices Leads and/or participates in projects related to medication management and/or medication use Assesses medication product and process compliance to identify operational risks and develops and implements risk reduction strategies Facilitate, coordinate, or conduct investigations and audits to identify areas of risk, draft a process improvement plan in collaboration with other departments or areas to improve compliance to address the risk, and monitor to ensure the process or program is following best practices and established standards Collaboration with multiple disciplines to produce quality outcomes related to organizational compliance with regulatory, state and federal standards Develop, achieve and maintain quality practices and outcomes and with accurate assessments of processes with independent initiative and collaboration among all disciplines  Coordinate quality services, with Clinical Services, in efforts to integrate, implement, and develop procedures, policies, and protocols Facilitate meetings with other hospital departments to assist with analysis, planning and implementation of compliance issues Partners with Quality and Safety, Risk Management, and clinical and administrative staff on an ongoing basis to optimize best practices Comply with current departmental and institutional policies, as well as, regulations set aside by regulatory bodies (i.e., The Food and Drug Administration, Drug Enforcement Administration, Department of Health, The Joint Commission, United States Pharmacopeia etc.) Attend regular committee meetings as assigned, and report as assigned Work independently, with minimal supervision Data collection, analysis, management, submission, and presentation Evaluation of processes for the purpose of determining compliance Conduct investigations and audits of current or potential areas of risk Develop audit processes and procedures to track and trend Map out risk assessments based on practice standards or workflow throughout the organization  Collaborate with departments to implement quality improvement processes to initiate or maintain compliance Other duties assigned Maintain and manage current and accurate documentation and records required for regulatory standards and audits Identify tools to increase efficiency and accuracy of auditing practices Assist with the development of up to date drug handling, diversion prevention, detection and reporting policies and procedures Assist in developing educational materials related to documentation, compliance or procedures Serve as intermediary between patient care units and pharmacy Take suitable action(s) or provides answers to questions of routine pharmacy procedures Facilitate risk assessments and monitor compliance processes associated with identified risk Interact with physicians, nurses, and other hospital personnel and must be able to refer questions concerns to the proper authorities Participate in Pharmacy and/or Hospital Committees, and QA assignments as assigned Facilitate the development of compliance with all legal, and regulatory guidelines, practice standards, and laws

COMPETENCIES:

The regulatory compliance specialist must demonstrate growth and development of knowledge required to maintain compliance with all applicable regulatory bodies.  The regulatory compliance specialist must be proficient in policy development and maintenance, including knowledge of the internal policy management system.  The regulatory compliance specialist must be adept at data collection/analysis/management/presentation, quality improvement, and project management.

COMPLIANCE:

The employee must comply with all federal and state standards.

EQUIPMENT USED:

All equipment and supplies of the department. This includes all dispensing, compounding, aseptic admixing, packaging, medication distribution, electronic data processing, and accounting and clerical equipment of the department.

CONTACTS:

Internal:  Administrative officers, department heads, junior and senior medical staff, medical students, nursing supervisors, general duty nursing personnel, inpatients. External:  Outpatients, vendor representatives, visitors, guests.

PHYSICAL DEMANDS:

Repetitive use of hands and fingers (e.g. computer keyboard).  May require lifting and carrying light loads (up to 40 pounds) and stooping or kneeling. Sitting, walking, or standing for long periods of time (4-8 hours) are often necessary.  Must be able to physically operate all equipment used in the job.

MENTAL DEMANDS:

This job requires the ability to work independently with minimal direct supervision, handle high stress, handle frequent interruptions, and adapt to changes in workload and work schedule.  Ability to set priorities, make critical decisions, and respond quickly in emergency situations.

WORKING CONDITIONS:

General working area is air conditioned, carpeted, and well-lighted. No exterior light or exposure.

RISK CLASSIFICATION:

Risk Category CATEGORY 2 - Tasks that involve no exposure to blood, body fluids, excretions, or secretions Job Hazards Potential for exposure to infectious patients or materials.  Potential for exposure to hazardous and toxic substances (including chemotherapy, cytoxic drugs, and cleaning solutions). Potential for sticks or cuts by needles and other sharp items.  Potential for musculoskeletal injuries if proper lifting and carrying techniques are not used.

 

update 11-25-24