Pharmacy Manager, Regulatory and Compliance Mount Sinai Heath System Full Time Days

Responsible for all regulatory and compliance related activities coordination record keeping and
presentation for all of the facilities within the Mount Sinai Health System pharmacies. Works with the
Compliance/Regulatory department to plan and coordinate activities of the pharmacy department that enable regulatory compliance to be achieved and maintained. Identifies and supports hospital departments and operational leadership in formulating integrating and implementing medication related policies procedures and programs that address regulatory compliance.

Competencies:
Demonstrates knowledge of the organizations Service Standards and incorporates them into the performance of duties.
Demonstrates knowledge of the Regulatory and Accreditation Requirements Rules and Codes and incorporates them into the performance of duties.

Reviews and disseminates information pertaining to Centers for Medicare & Medicaid Services (CMS) The Joint Commission (TJC) New York State Department of Health (NYSDOH) New York State Office of Mental Health (NYSOMH) and other compliance activities.
Identifies the needs for as well as designs implements and monitors process/activities to assure pharmacy compliance with standards and facilitates ongoing survey readiness.
Pharmacy/Nursing point person for workflow and process updates as it relates to diversion.
Oversees the Drug Diversion Prevention Program including the implementation and maintenance of the Drug Diversion Prevention software
Is accountable for all aspects of drug diversion education prevention monitoring investigation and reporting in an effort to reduce harm to patients.
Facilitates prioritization of improvement activities related to controlled substance management and shares knowledge as a subject matter expert.
Oversees the compliance as it relates to controlled substance record keeping.
Identifies areas for reporting of required pharmacy information to regulatory agencies.
Communicates departmental progress areas on concern and problems.
Collaborates with Administrative and Clinical leadership in implementing the Regulatory Readiness Plan. Represents the regulatory perspective through participation on pertinent hospital committees.
Develops and maintains required resource and in-services materials for staff.
Pursues a planned program of professional development through continuing education seminars webinars and applicable journal newsletter and participates in scholarly/professional activities.
Provides a forum for interdisciplinary dialogue for direct care providers (i.e. pharmacy/nursing committee).
Serves as a member of the pharmacy departments leadership team.
Supports an environment dedicated to the safety of our patients and staff and facilitate safety-improvement changes in the medication-use physical environment (USP 797/800).
Participates in the development and assessment of a pharmacy quality improvement program.
Designs and manages a QA (Quality Assurance) program for order verification and comprehensive pharmaceutical care.
Oversees all aspects of medication-related policies and procedures i.e. policies and procedures are disseminated enforced effective applicable up-to-date and meet regulatory standard.
Precepts pharmacy students and residents as assigned.
Designs and manages pharmacys compliance audit program.

Duties and Task:
Survey participation for accreditation reaccreditation validation allegation unannounced regulatory surveys. Provides consultation for pre-survey rounds survey preparation planning and follow-up for corrective action implementation.
Orients educates and works with internal and external staff in performing survey preparation activities including but not limited to Mock Tracers Secondary Tracers Safety and Weekly Walk rounds as well as the Periodic Performance Review (FSA) tool.
Plans organizes and coordinates with other departments receipt of information/documentation required to demonstrate compliance with standards and regulations.
Coordinates Pharmacy Regulatory and Compliance initiatives for all pharmacies in the enterprise and ensures all pharmacies are within compliance for Joint Commission.
Implements appropriate changes to policies and procedures based on identified interdisciplinary trends.
Keeps record of all competencies for all Mount Sinai Health System pharmacy sites. Designs and implements CQI (Continuous Quality Improvement) initiatives.

Minimum Qualifications:
Bachelor of Pharmacy Degree. Current New York State Pharmacist License.
Five (5) years of hospital experience including experience in process/workflow design and related policy procedure.

Preferred:
Advanced Degree (M.S. MHA PharmD)
PGY2 HSPAL
ASHP Pharmacy Accreditation and Regulatory Compliance Certificate

Non-Bargaining Unit 600 - HSO Pharmacy - MSH Mount Sinai Hospital