Director of Medication Safety and Regulatory Compliance

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The Director, Medication Safety and Regulatory for the University of Miami Health System (UHealth) assume responsibilities for all medication safety and regulatory compliance programs. This position reports to the Chief Pharmacy Officer with quality, regulatory compliance, safety outcomes and performance improvement initiatives consistent with the goals of the system.

Safety and Compliance Oversight

Essential Duties:

• Assesses all aspects of the safety processes, including the assessment of safety activities, development of curricula to meet the needs, implementation of safety programs/offerings, and the outcomes of such programs/offerings.
• Develops, reviews, and revises procedures, both directly and on a consultation basis, safety records, performance checklists, orientation competency maps, patient education materials, etc., as they relate to staff/patient safety, including assisting in incorporating same into orientation and all applicable continuing education.
• Acts as a resource and mentor to clinical instructors in relation to clinical and safety initiatives, teaching strategies, and evaluation of those initiatives in the clinical setting.
• Assist Directors, Management and Clinicians in planning and presenting continuing safety programs/courses.
• Collaborate with various hospital departments to ensure regulatory compliance of medication management processes.

Maintain and update the Pharmacy Policy and Procedure Manual, medication-related policies in the hospital manuals, and Pharmacy regulatory educational materials to ensure compliance with.

Compliance Execution, Education & Training

Essential Duties:

• Monitors all medication safety activities and educational outcomes through Performance Improvement (PI) activities, reviews PI data results, develops educational programs based on Performance Improvement data results, implements performance improvement activities as they relate to the specific job requirements.
• Interpret regulatory requirements and assist with educational materials for Pharmacy and all hospital staff on a routine basis.
• Ensure medication management compliance with state and federal laws, accreditation, professional and other regulatory agencies standards and licensure requirements.

Develop, coordinate, and perform gap analyses, tracers, and other risk evaluations to ensure regulatory compliance.

Administrative Organizational Goals and Responsibilities and Patient Care

Essential Duties:

• Develops working knowledge of the Medication Management Practice standards and communicates these standards to all of management and Coordinates controlled-substance surveillance program.
• Maintain abreast of all current regulatory standards relevant to pharmacy practice.
• Coordinate the UHealth controlled-substance surveillance program.
• Ensure controlled substance accountability through collaborations with hospital departments including but not limited to Anesthesia, Nursing, Risk Management, Compliance, and Human Resources on policies/procedures and processes.
• Identifies the needs of the patient population served, modifies and delivers care that is specific to those needs (i.e., age, culture, hearing and/or visually impaired, etc.). This process includes communicating with the patient, parent, and/or primary caregiver(s) at their level (developmental/age, educational, literacy, etc.).

This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.

CORE QUALIFICATIONS                                                                                        

Education:

Bachelor’s in pharmacy or Pharm.D. degree, Master’s or MBA Preferred.

Certification and Licensing:

Active Florida Pharmacist license obtained within 6 months of hire.

Experience:

Minimum 10 years of relevant experience with demonstrated expertise in Medication Safety and regulatory compliance for all service lines of pharmacy (TJC, BOP, URAC, ACHC, Home Infusion and other regulatory agencies)

Knowledge, Skills and Attitudes:

• Ability to work effectively with a multidisciplinary team and handle multiple responsibilities.
• Ability to execute and operationalize initiatives.
• Knowledge of healthcare safety, clinical, regulatory and operational management principles.
• Ability to execute and operationalize enterprise strategies set by executive leadership.
• Ability to direct, manage, and evaluate multi-site, multi-service pharmacy operations.
• Strong analytics, financial and operational management skills, with ability to balance budgets and optimize contracts.
• Ability to lead, motivate, and develop high-performing operational teams.
• Ability to leverage analytics, AI, and cohort insights to achieve measurable improvements in patient care and financial outcomes.

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The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.

The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.

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