When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives.
Under the direction of the BILH Pharmacy Assistant Vice President, Regulatory and Compliance, the Drug Diversion Prevention and Regulatory Compliance Program Manager leads system-wide implementation and optimization of diversion analytics software and regulatory compliance initiatives across the Beth Israel Lahey Health (BILH) System. This role works collaboratively with the BILH Controlled Substance Oversight Committee and hospital compliance teams to identify ways to standardize best practices and reduce risk by leveraging reporting tools and technology to prevent, detect, investigate and mitigate drug diversion and compliance risk. Responsibilities include designing and executing audits, educating site-level coordinators on regulatory updates and partnering with compliance and risk management teams to improve medication safety and maintain high compliance standards throughout the BILH System.
Job Description:
Primary Responsibilities:
1. Leads system-wide implementation, optimization and ongoing enhancement of drug diversion analytics software while optimizing use of diversion analytics technology to improve diversion detection and response
2. System-wide regulatory oversight of pharmacy compliance programs, ensuring adherence to federal, state and local laws and regulations
3. Establishes and maintains a quality assurance program that supports continuous improvement and ensures effectiveness of controlled substance surveillance programs and pharmacy regulatory compliance programs.
4. Monitors compliance with use of drug diversion analytics platform and reports out to BILH Controlled Substance Oversight Committee
5. Supports local oversight committees as a liaison to drive clear communication and operational alignment
6. Collaborates with entity leaders in responding to suspected diversion incidents and serves as point of contact to help with data analytics reports generation for diversion investigations
7. Develops and oversees an audit program and monitoring activities to ensure compliance and identify areas of risk. Communicates, monitors and analyzes data and reports pharmacy non-compliance
8. Provides ongoing education to diversion coordinators at the sites and supports the development and delivery of compliance training and diversion prevention programs including onboarding and annual education
9. Conducts quarterly regulatory compliance visits to pharmacy sites to assess compliance and identify areas of potential non-compliance and areas for implementation of best practice
10. Leads and performs diversion risk rounds at BILH sites to proactively identify high risk activities and support staff education, and promote best practices in controlled substance management
11. Identifies compliance gaps and areas of risk and supports changes to enhance effectiveness of controlled substance surveillance and regulatory adherence
12. Ensures that required internal and external regulatory reporting occurs as required following each diversion event in a timely and accurate manner
13. Participates and leads multidisciplinary committees and workgroups as appropriate. Participates in meetings, serves and leads committees related to improvement and standardization of diversion prevention and surveillance and pharmacy regulatory compliance
14. Supports system adherence and compliance to USP <797> (Pharmaceutical Compounding – Sterile Preparations) and USP <800> (Hazardous Drugs – Handling in Healthcare Settings)
15. Updates guidelines, policies, standard operating procedures, and training materials to reflect current practice and regulatory requirements
16. Maintains current knowledge of DEA, FDA, MA Department of Public Health, MA Board of Pharmacy, Joint Commission and EPA regulations related to controlled substances and compliance with internal policies and procedures
17. Manages assigned compliance related and diversion prevention related projects with site leaders and key stakeholders to meet system goals
18. Performs other duties as assigned
Required Qualifications:
1. High School diploma or GED required.
2. Bachelor’s Degree preferred.
3. Massachusetts registered pharmacy technician license required
4. Certified Pharmacy Technician (CPHT) required
5. At least 3 years of work experience in hospital pharmacy is required.
6. 1-3 years related work experience required in controlled substances handling processes and/or controlled substance analytics.
7. Knowledge of controlled substances surveillance and management systems and techniques; federal and state regulatory compliance requirements; and auditing techniques.
8. Advanced skills with Microsoft applications which may include Outlook, Word, Excel, PowerPoint or Access and other web-based applications. May produce complex documents, perform analysis, and maintain
9. Ability to develop strong relationships with diverse groups of professionals (physicians, nurses, administration, etc.)
Preferred Qualifications:
1. Advanced Certification in Controlled Substances Diversion Prevention
2. Advanced Certification in Regulatory Compliance
3. Certification in Investigative Techniques
Competencies:
1. Decision Making: Ability to make decisions that are guided by general instructions and practices requiring some interpretation. May make recommendations for solving problems of moderate complexity and importance.
2. Problem Solving: Ability to address problems that are varied requiring analysis or interpretation of the situation using direct observation, knowledge and skills based on general precedents.
3. Independence of Action: Ability to set goals and determines how to accomplish defined results with some guidelines. Manager/Director provides broad guidance and overall direction.
4. Written Communications: Ability to communicate clearly and effectively in written English with internal and external customers.
5. Oral Communications: Ability to comprehend and converse in English to communicate effectively with medical center staff, patients, families and external customers.
6. Knowledge: Ability to demonstrate full working knowledge of standard concepts, practices, procedures and policies with the ability to use them in varied situations.
7. Team Work: Ability to act as a team leader for small projects or work groups, creating a collaborative and respectful team environment and improving workflows. Results may impact the operations of one or more departments.
8. Customer Service: Ability to provide a high level of customer service to patients, visitors, staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving. Ability to remain calm in stressful situations.
Social/Environmental Requirements:
• Work requires close attention to task for work to be accurately completed. Intermittent breaks during the work day do not compromise the work.
• Work is varied every day and the employee needs to be adaptable to respond to these changes and use independent judgment and manage priorities.
• Potential exposure to adverse environmental conditions
o Daily: No substantial exposure to adverse environmental conditions
• Health Care Status: NHCW: No patient contact. Health Care Worker Status may vary by department.
Sensory Requirements:
• Close work (paperwork, visual examination), Color vision/perception, Visual clarity <3 feet, Conversation, Monitoring Equipment, Telephone.
Physical Requirements:
• Sedentary work: Exerting up to 10 pounds of force occasionally in carrying, lifting, pushing, pulling objects. Sitting most of the time, with walking and standing required only occasionally.
• The job requires frequent sitting. Keyboard use. There may be occasional walking, standing.
Pay Range:
$88,000.00 USD – $117,000.00 USD
The pay range listed for this position is the annual base salary range the organization reasonably and in good faith expects to pay for this position at this time. Actual compensation is determined based on several factors, that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law.
