Regulatory Compliance Pharmacist

Overview

8a-4:30p / Full Time / 40 Hours

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Job Summary:

We are seeking an experienced pharmacist to oversee our regulatory and compliance program as it relates to federal and state requirements (i.e. GA BOP, DEA, DSCSA, FDA), diversion prevention, controlled substance accountability, proper medication handling, accreditation survey readiness, adherence to USP standards, and patient safety initiatives.

Primary duties and responsibilities:

• Operational Excellence:
  Oversees and optimizes data analytics related to the identification and prevention of controlled substance mismanagement and drug diversion.
• Operational Excellence:
  Coordinates timely investigations of suspected drug diversion in collaboration with the appropriate site leaders and the Drug Diversion Response Team.
• Operational Excellence:
  Assists with education and coaching following a confirmed case of diversion and reports/ documentation is complete timely adhering to regulatory requirements.
• Operational Excellence:
  Provides education, coaching and training as necessary following discrepancies and / or deviation from standard operating procedures.
• Operational Excellence:
  Performs audits related to regulatory requirements including, but not limited to, manual and electronic USP and compliance related documentation.
• Operational Excellence:
  Assists with investigating pharmacy medication safety events and participates in relevant multi-disciplinary meetings.
• Operational Excellence:
  Evaluates and facilitates workflow modifications to prevent diversion and/or meet regulatory and accreditation requirements.
• Operational Excellence:
  Serves as the primary backup to the controlled substance coordinator as needed and as applicable.
• Operational Excellence:
  Participates in proactive review and audits of high-risk diversion practices and required clinical and operational documentation.
• Operational Excellence:
  Reviews and presents key performance indicator data related to regulatory, compliance, and accreditation to local and system leadership.

• Collaboration and Communication:
  Works collaboratively with both internal and system pharmacy, operational, and clinical leadership.
• Collaboration and Communication:
  Maintains open and effective communication with all stakeholders, providing updates and insights into findings.
• Collaboration and Communication:
  Attends and participates in system and key stakeholder meetings related to drug diversion, compliance, safety, security, and accreditation.
• Collaboration and Communication:
  Provides education sessions for pharmacy, nursing, and/or provider teams as needed.
• Collaboration and Communication:
  Identifies opportunities to improve patient safety, medication management, and accreditation best practices.
• Collaboration and Communication:
  Promotes standardization and best practice implementation where appropriate.
• Collaboration and Communication:
  Prepares financial/operational/clinical/quality analysis materials for process improvement.
• Collaboration and Communication:
  Serves as the primary liaison between pharmacy operations, compliance, and leadership to ensure consistent adherence to accreditation and regulatory requirements.

• Regulatory and Compliance Program Development:
  Completes and maintains documentation as it relates to investigational activities, compliance tasks, and third-party audits, as applicable.
• Regulatory and Compliance Program Development:
  Coordinates and/or participates in safety event response team meetings and ensures timely follow-up.
• Regulatory and Compliance Program Development:
  Tracks and assists with REMS program compliance and audits.
• Regulatory and Compliance Program Development:
  Audits receiving, ordering, and processing of controlled substances and other high-risk medications.
• Regulatory and Compliance Program Development:
  Ensures adherence to federal, state, and local regulations including licensing, certifications, training, and collaborative practice agreements as applicable.
• Regulatory and Compliance Program Development:
  Assists leadership in inspection or survey preparation and readiness related to BOP, GDNA, DEA, TJC, URAC, ACHC, and any other regulatory agencies.
• Regulatory and Compliance Program Development:
  Supports adherence to USP standards including , , , and as applicable.
• Regulatory and Compliance Program Development:
  Leads outcomes reporting and benchmarking related to accreditation as applicable.
• Regulatory and Compliance Program Development:
  Supports controlled substance,…