Core Responsibilities:
Regulatory & Compliance Oversight:
- Serve as the Pharmacist-in-Charge (PIC) for the licensed facility, ensuring compliance with all federal and state pharmacy rules, regulations, and laws.
- Maintain PIC responsibilities across various state jurisdictions, ensuring compliance for facility licensure.
- Monitor and interpret pharmacy laws, regulations, and guidance from governing bodies such as State Boards of Pharmacy, DEA, FDA, CMS, and other entities.
- Lead regulatory audits, including facility license renewals, change of ownership filings, and other licensing initiatives.
- Develop, implement, and maintain policies and procedures to ensure compliance with REMS, DSCSA, HIPAA, URAC, and internal company standards.
- Investigate and resolve compliance issues, quality-related medication incidents, and deviations using CAPA (Corrective and Preventive Action) processes.
- Maintain strict confidentiality of patient health information in compliance with HIPAA standards.
Clinical Leadership & Pharmacy Operations:
- Oversee clinical services, including drug reviews and patient safety initiatives, to ensure safe and effective medication use.
- Collaborate with prescribers, manufacturer clients, and other healthcare providers to resolve clinical escalations and enhance therapy outcomes and patient experiences.
- Evaluate and implement technological and workflow improvements to optimize prescription processing, documentation, and patient safety.
- Oversee prescription accuracy and ensure safe medication use throughout the pharmacy workflow.
- Oversee prescriptions for clinical accuracy, contraindications, and drug interactions during the order verification process.
Governance, Quality, & Cross-Functional Collaboration:
- Collaborate to promote a just culture, regulatory transparency, and continuous quality improvement.
- Collaborate with pharmacy operations, compliance and quality teams, corporate leadership, and shared services to align pharmacy performance with organizational goals.
- Partner with the corporate quality team to track and analyze performance data, monitor patient safety events, and implement corrective actions to enhance service quality.
- Represent the pharmacy in communications with regulatory bodies, REMS administrators, accreditation bodies, and manufacturer clients.
- Lead and support initiatives for the pharmacy’s quality management and continuous quality assurance programs.
Operational Strategy & Workflow Optimization:
- Evaluate and implement workflow and technological improvements to enhance operational efficiency and patient care.
- With operations, monitor key performance indicators (KPIs), production goals, and staff performance metrics to improve operational performance or enhance workflow processes and training initiatives.
- Use performance metrics to guide staffing decisions, identify process delays, and improve documentation standards.
- Ensure accurate and complete documentation of services rendered, products delivered, and patient education.
Personnel Management & Development:
- Supervise and enforce workflow standards, ensuring pharmacist oversight and operational consistency.
- Oversee pharmacy opening and closing procedures, either directly or through delegation to staff.
- Manage onboarding, training, continuing education, and competency assessments for pharmacy personnel.
- Provide coaching, conduct performance reviews, and hold staff accountable to meet productivity and compliance goals.
- Promote interdepartmental education for pharmacy personnel, healthcare providers, and patients.
Cross-Functional & External Collaboration:
- Represent the pharmacy for client audits and quarterly business reviews. Present during capabilities presentations and support in client pitches.
- Serve as the pharmacy’s regulatory representative in interactions with boards of pharmacy, manufacturer clients, auditors, and other accreditation bodies.
- Partner with corporate teams to implement and monitor compliance reporting tools, such as LicenseComply, RegComply, and QuREy.
- Coordinate with legal, compliance, operations, and shared services teams to ensure cross-functional alignment.