Senior Pharmacy Compliance Analyst

Job Purpose Statement:

The Senior Pharmacy Compliance Analyst (SPCA) is responsible for the review and evaluation of healthcare regulatory compliance controls and programs. Develops regulatory policies and systems from a strategic perspective; keeps abreast of regulatory issues, plans for changes and / or integration as new healthcare affiliations are assumed. Provides education and consultation to hospital and medical staff regarding the integration of compliance regulatory standards with programs and operations. Acts as a channel of communication to direct compliance issues to appropriate resources for investigation and resolution. Ensures issues and concerns are being appropriately evaluated, investigated and resolved. Develops and maintains policies and procedures for the general operation of the compliance program and its related activities. (For primary focus in privacy, see "Privacy" job standards.)

Essential Functions:

• Conduct and oversee all aspects of the investigation process.
  • Serves as primary contact and lead investigator for all reported and/or alleged diversion incidents.
  • Conduct interviewing of workforce involved in alleged diversion activities, authoring investigative reports, and conducting forensics/data analysis. The SPCA should have a strong background and understanding of electronic health records (EHR), automated medication dispensing systems, and ability to analyze data and make inferences from disparate systems and reports as a part of the investigation process.
  • Assist and lead in partnership with the BCH-Oakland Compliance Officer, committees and other drug diversion prevention program activities in partnership with Pharmacy Leadership.
• Process Improvement of Controlled Substance handling
  • Assists in the development and monitoring of corrective action plans or projects resulting from internal monitoring and/or third party audits or external surveys.
  • Leads and utilizes expertise in developing, planning and coordinating projects, actively participating on pharmacy committees/workgroups, data analyses/forensics for investigation of diversion events, and assessment of pharmacy operations auditing and monitoring program.
  • Monitors controlled substance handling processes and audits for compliance with current policies and procedures.
  • Monitors regulatory changes and organizational trends to identify needs for policy and procedure updates and facilitates dissemination of drug diversion prevention policies and procedures to workforce.
  • Analyze complex data models and make inferences from disparate systems and reports as a part of the investigation process. Track and trend diversion-related data from across the health system to identify and prevent diversion of controlled substances.
• Regulatory Compliance
  • Maintains current working knowledge of relevant DEA and CA Board of Pharmacy regulations related to controlled substance management and diversion activities.
  • Evaluates risk and and/or new regulations to identify educational needs for departments and workforce.
  • Applies extensive industry knowledge and ability to handle complex investigations and operational inquiries of broad scope.
  • Work closely with Pharmacy leadership, Nursing Leadership, Legal counsel, Risk Management, external agencies and management to manage regulatory inquiries, and other mandatory reporting requirements.
  • Provides education, advice, and guidance to hospital and medical staff regarding all aspects of the Drug Diversion Prevention Program and also coordinates integrating standards and regulations across BCH-Oakland departments and multi-disciplinary functions.
• Lead UCSF BCH OAK Diversion Prevention Program
  • Oversees the development, implementation, and management of the BCH-Oakland Children¿s Hospital diversion prevention program. This role will collaborate with Pharmacy Operations and be the primary lead for drug diversion investigations, conduct routine surveillance, and assist in the program development and governance for the drug diversion prevention program.
  • Develops policies and procedures for incident response and the investigation framework
  • Collaborates with Pharmacy Operations on the development of monitoring/auditing tools, and education/training for workforce on systems and processes to detect and prevent drug diversion.
  • Develops and implements Bluesight/Pyxis online training modules and other education guidance and project development as well as other educational activities as assigned.
  • Collaborates with Pharmacy Director, developing and creating content for interdisciplinary meetings reporting out on diversion prevention.
• Other
  • Ensures allegations of suspected and/or actual diversion are being appropriately evaluated, investigated and resolved.
  • Collaborates and consults with pharmacy operations and cross-functional groups in the areas of policy development, risk assessments, and monitoring of compliance requirements and implementation of corrective action plans.
  • In collaboration with Pharmacy Operations, responsible for ensuring routine controlled substance auditing occurs including but not limited to review of CII Safe reports and analysis of unresolved discrepancies and medication overrides.
  • Other duties as assigned.

People Leadership Responsibilities: This role does not have any formal people leadership responsibilities, but the incumbent may be expected to provide general supervision to more junior colleagues (i.e., assigning tasks and activities, providing instructions, coordinating work schedules)

Financial Responsibilities: May be assigned tracking and reporting responsibilities for an established annual budget.

Technical Knowledge

• Proficient in all MS Office applications, BI/database applications and reporting tools.
• Stays up to date on and has the ability to apply current Board of Pharmacy and DEA reporting requirements, and apply industry standards to BCH-Oakland operations. Ability to interpret regulations and collaborate with subject matter experts in assessing policies
• Skilled written and verbal communicator. Applies discretion and professional judgment regarding sensitive and confidential issues. Presents professional demeanor and is a customer service role model in interactions with internal and external customers, organizations, personnel, researchers, and physicians
• Role models interpersonal and problem solving skills. Ability to listen actively, think critically, persuade, advice, and counsel.
• Ability to work in high stress environment with individuals of diverse cultural backgrounds. Proven project management and database management skills.
• Advanced organizational and project management skills. Demonstrates flexibility and handles multiple and competing responsibilities; sets goals, prioritizes tasks, and identifies resources
• Knowledge of automated medication dispensing systems (i.e. Pyxis), electronic health record (i.e. EPIC), and third party drug diversion monitoring software applications (i.e. Bluesight).
• Leads and manages special projects as assigned.. Research issues as needed, assessing implications on operations and administrative processes. Performs other duties as assigned.
• Strives for continuous professional development in maintaining and increasing knowledge and skills related to compliance, drug diversion, systems management, analysis methodology, training, and report writing skills for compliance.
• Ability to function independently and within a team with minimal supervision, demonstrating excellent judgment, and attention to process and detail. Utilizes discretion, confidentiality, and tact to deal with sensitive issues. Ability to interact with all levels of staff and to set priorities and manage multiple demands effectively.

Minimum Education:

• High School Diploma required
• Bachelor¿s degree in Science or related Research or Technical Field and / or equivalent experience / training preferred
• Master's degree or equivalent experience in a hospital or pharmacy operations preferred

Minimum Experience:

A minimum of 5 to 8 years of combined experience working in a large health care organization in at least one of the following areas: hospital operations, pharmacy operations, pharmacy benefit manager (PBM), retail pharmacy, and/or pharmaceutical manufacturer.

Additional Minimum Requirements:
Pharmacy Tech Certification Board (PTCB) preferred
Certified through a State Board of Pharmacy (preferably CA), and possess a valid Technician License preferred
Certified in Healthcare Research Compliance (CHRC) preferred
Certified in Healthcare Compliance (CHC) preferred
Certified in Healthcare Privacy and Compliance (CHPC) preferred

Physical Requirements:
Sit: Up to 8 hours/day
Stand/Walk: 3-6 hours
Bend/Stoop: Up to 3 hours
Reach: Up to 3 hours
Rep Use of UE/Grasp: Up to 8 hrs
Lift/Push/Pull: 15 lbs
This job requires the ability to hear alarms clients and/or instruction. The ability to see accurately from 20 inches to 20-ft. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function of this position.