Ambulatory/Retail Clinical Pharmacy Specialist, Regulatory

Ambulatory/Retail Clinical Pharmacy Specialist, Regulatory at Penn Medicine

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Penn Medicine is seeking a full-time, day shift Ambulatory/Retail Clinical Pharmacy Specialist, Regulatory for the Hospital of the University of Pennsylvania (HUP).

Summary

The Ambulatory/Retail Clinical Pharmacy Specialist, Regulatory (CPS-R) ensures pharmacy compliance related to regulatory and accreditation standards and regulations. The individual will be responsible for the development and execution of internal audits by examining records, reports, and operating practices, against established controls to ensure all relative operations adhere to the laws regulating the industry. The individual must demonstrate a highly organized ability to integrate within the interdisciplinary healthcare team and current structure of the pharmacy department. As a contributing member of the Quality Committee, this individual will act as the Compliance Officer for the committee and be responsible for the management of medication safety issues and coordinate the development of safety guidelines. The individual will dedicate 25% of time dedicated to applicable initiatives of the Quality Committee. In addition, this individual will ensure the relative pharmacy policies and procedures are in compliance with medical literature and regulatory organizations. The CPS-R will also participate in the design and implementation of management controls and practices to ensure that all business units are compliant with Federal, State and local rules and regulations, including, but not limited to, FMCSA, CA BIT, PHMSA, CSA, OSHA, FSMA, AIB and IFTA. The CPS-R will conduct process owner interviews and document end-to-end process flow charts for in-scope processes while updating existing documentation as changes occur. The individual will collaborate with key stakeholders to ensure consistency and in preparation of internal audits. The CPS-R will participate in spontaneous mock audits or walkthroughs with process owners to ensure process and control documentation are accurate. The individual will monitor, follow up and document corrective actions to ensure complete pharmaceutical compliance. In addition, the individual will support leadership during external audits by coordinating information requirements.

Responsibilities

• Legally and ethically ensures pharmacy practices and operations are in compliance with all applicable industry regulations.
• Conducting on-going, in-depth analysis of current regulations and ethical standards in the pharmacy industry. Demonstrating the ability to understand how to interpret these regulations/standards, and how they fit into pharmacy operations.
• Ensures and sustains compliance with all relative regulatory and accreditation organizations.
• Contributes to organizational performance improvement by recommending changes for improved services to supervisor.
• Monitors, assesses and makes necessary adjustments to departmental operations to insure quantity and ensure quality of pharmaceutical care services.
• Control pharmaceutical safety while increasing productivity and improving quality.
• Ensure Pharmacy Department’s medication policies and procedures are current with the latest advances within the pharmacy industry.
• Maintains patient satisfaction through appropriate provision of pharmaceutical care services.
• Participates in quality assurance programs to enhance patient care and helps to coordinate applicable committee meetings with key stakeholders.

Credentials

• Active PA Pharmacist License (Required)

Education or Equivalent Experience

• Bachelors of Science in Pharmacy or PharmD from an accredited School of Pharmacy (Required)
• PGY1 Pharmacy Residency (Preferred)
• PGY2 Pharmacy Residency in Medication Safety (Preferred)
• 3+ years experience (Required)
• Candidates without PGY1 or PGY2 training must be Board Certified with relevant experience (Required)

Key skills/competency

• Regulatory compliance
• Medication safety
• Internal audits
• Quality assurance
• Pharmacy operations
• Accreditation standards
• Policy development
• Interdisciplinary collaboration
• Pharmaceutical care
• Risk management