The Pharmacy Regulatory Surveillance Manager is responsible for ensuring pharmacy compliance with the regulatory agencies including but not limited to: The Joint Commission, Department of Health Services, DEA, and California State Board of Pharmacy. He/she is responsible for supervising the departmental performance improvement program.
Employee takes initiative to continually learn and maintain clinical and regulatory knowledge.
- Ensures department compliance with state and federal laws, accreditation, professional and other regulatory agencies standards and licensure requirements:
* Maintains abreast of all current regulatory standards relevant to pharmacy practice.
* Interprets regulatory requirements and educates Pharmacy and medical center staff on a routine basis.
* Collaborates with various medical center departments on ensuring regulatory compliance of medication management processes.
* Develops, coordinates, and performs gap analyses, tracers, and other risk evaluations to ensure regulatory compliance.
* Maintains and updates the Pharmacy Policy and Procedure Manual, medication-related policies in the hospital manuals, and Pharmacy regulatory educational materials to ensure compliance with the regulatory requirements.
* Maintains records of authorized medication storage areas and ensures their monthly inspection as required.
* Coordinates medication recalls and ensures complete documentation. - Coordinates pharmacy staff training and competencies. - Coordinates the medical center controlled substance surveillance program:
* Collaborates with medical center departments including but not limited to Anesthesia, Nursing, Risk Management, Office of Licensure Accreditation and Regulation, and Human Resources on policies/procedures and processes for ensuring controlled substance accountability.
* Develops, coordinates, and performs audits of controlled substance transactions to ensure dose accountability.
* Coordinates controlled substance medical center committees.
* Maintains complete and accurate records of controlled substance distribution.
* Educates medical center staff on controlled substance requirements, policies, and best practices for ensuring accountability.
Comprehensive knowledge of common disease states and pathologies and their treatment. Ability to apply current pharmacological and biopharmaceutical principals for the selection and use of drug products in a clinical setting. Demonstrated competency in Sterile Manufacturing, pharmaceutical calculations, compounding, pharmacokinetics and drug preparation. Ability to comprehend patient management plans. Excellent verbal and written communication skills. Ability to serve as preceptor in teaching programs. Ability to prioritize work flow. Knowledge of law, regulations and standards relative to institutional pharmacy practice. Ability to develop and implement cost containment measures and new revenue sources.
Physical Requirements (physical abilities essential to perform the job): - Frequent standing; walking, bending; reaching, occasional sitting, pushing & pulling, lifting of materials up to 40 pounds for distances to 10 feet. - Responsiveness to auditory alarms and communication devices including: telephones, beepers, fire alarms, and mechanical failure alarms. - Sufficient mobility to access equipment, patients and other customers. - Able to read information on medication labels
Work Environment (work environments, hazards and exposures the employee may encounter on the job): - Hazardous drug and investigational biologic drugs preparation and handling - Exposure to minimal but constant noise levels. - Repetitive hand motions. - Some functions may include incidental exposure to hazards associated with preparation of cytotoxic medications. - Some functions may require use of protective gear such as gloves and fluid-resistant coats.
Providing healthcare for more than 100 years, Cedars-Sinai has evolved into one of the most dynamic and highly renowned medical centers in the world. Along with caring for patients, Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. This attracts exceptional talent to Cedars-Sinai, including world-renowned physician-scientists who seek a place where they can both conduct research and see patients--the ideal formula for discovery and its translation into cures. Our patients benefit from access to doctors at the top of their fields, and our researchers have an ideal community in which to study the impact of healthcare challenges, and reflect that knowledge in their research. The greater Los Angeles area in which Cedars-Sinai resides possesses unparalleled cultural and ethnic diversity which offers outstanding opportunities for translational and clinical research... and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major teaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly competitive graduate medical education programs in more than 50 specialty and subspecialty areas, a graduate program in biomedical sciences and translational medicine, a clinical scholars program directed towards junior physicians with aspirations to become clinical scientists, and post graduate training opportunities.There are more than 250 full-time faculty members at Cedars-Sinai. The voluntary medical staff, comprised of more than 2,200 specialty board-certified or board-qualified physicians, represent all of the specialties and subspecialties and collaborate with full-time medical staff in the teaching responsibilities of the graduate medical education programs.