When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives.
The Manager, Pharmacy Regulatory Compliance and Medication Safety for Retail Pharmacies will ensure the pharmacies operate in accordance with state and federal laws, and oversee adherence to standards and manage risks associated with medication handling and patient privacy. The Manager of Pharmacy Regulatory Compliance and Medication Safety for Retail Pharmacies will work collaboratively with the Pharmacy Quality, Accreditation, and Licensing Manager to ensure that state and federal regulatory compliance standards are met while maintaining applicable required accreditation standards across BILH Pharmacies that hold a Retail Drug Store Permit or the state equivalent in other states of operation. The Manager of Pharmacy Regulatory Compliance and Medication Safety for Retail Pharmacies.
Job Description:
Primary Responsibilities:
Develop, implement, and oversee the pharmacy's regulatory compliance program, including creating and updating policies and procedures.
Conduct regular audits of pharmacy processes and records to identify areas of risk and ensure adherence to regulations such as those from the DEA and state boards of pharmacy.
Monitor and interpret new and existing federal, state, and local regulations and standards such as CMS and advise on their impact.
Identify compliance risks and collaborate with management to develop and implement corrective action plans to address issues like medication diversion and billing errors.
Assist with responding to inquiries, inspections, and complaints from regulatory bodies.
Analyze compliance data and reports to monitor performance and identify trends.
Stay up to date on state and federal Regulatory Changes and upcoming Regulatory Changes impacting BILH Pharmacies holding a Retail Drug Store Permit
Ensure that Policies are up to date to meet regulatory requirements of applicable State Boards of Pharmacy, DEA, and other regulatory agencies
Work closely with Accreditation team to make sure that policies are aligned to meet both Accreditation and Regulatory requirements
Perform quarterly regulatory compliance visits in each pharmacy location with Pharmacy Managers to assess compliance and identify areas of potential non-compliance
Work collaboratively with Director of Retail Pharmacy Services, Director of Specialty Pharmacy, Director of Home Infusion Pharmacy Services, and other Directors/Managers as needed to ensure regulatory compliance
Work with Accreditation team to ensure that all required trainings are in place for all pharmacy associates to meet Regulatory and Accreditation requirements
Work with AVP of Regulatory and Compliance to ensure Retail pharmacy workflows, policies, and procedures align with system polices and procedures where applicable
Ensure compliance with DSCSA requirements
o Work collaboratively with Pharmacy and Inventory teams to ensure compliant processes are in place to meet all DSCSA requirements
Ensure compliance with USP 800 and other applicable USP requirments for Retail Pharmacies
Assist Directors/Managers with Board of Pharmacy applications, waivers, and other communications
Chair Retail Controlled Substances Oversight Committee and assure compliance with all DEA regulations.
Implement and chair a retail Medication Safety Committee to review trends in medication safety events and recommend improvements to processes.
Investigate medication errors and adverse drug events to identify trends and contributing factors.
Develop and implement strategies, protocols, and policies to prevent medication errors and enhance safety systems.
Ensure adherence to regulatory guidelines, monitor compliance, and manage the reporting of medication-related incidents.
Work with multidisciplinary teams, safety committees, and leadership to champion safety initiatives.
Conduct audits, monitor medication-use systems, and participate in quality improvement projects to optimize safety.
Fosters a culture of safety.
Has the authority to direct and support employees daily work activities. Has the direct responsibility to undertake the following employment actions: hiring, termination, corrective action and performance reviews.
Required Qualifications:
Bachelor's Degree in Pharmacy
Massachusetts Pharmacist License
5-10 years relevant work experience in Pharmacy
5+ years as a Pharmacy Manager in Massachusetts
Experience with Board of Pharmacy Retail Compliance inspections
Knowledge of regulatory requirements and best practices in medication safety
Skilled in Microsoft applications which may include Outlook, Word, Excel, PowerPoint or other web-based applications. May produce complex documents, perform analysis and maintain databases.
Preferred Qualifications:
Experience working with State Boards of Pharmacy and DEA
Experience with root cause analysis and quality improvement
Extensive knowledge of Retail Pharmacy Regulatory processes and applications
Competencies:
Decision Making: Ability to make decisions that are guided by precedents, policies and objectives. Regularly makes decisions and recommendations on issues affecting a department or functional area.
Problem Solving: Ability to address problems that are highly varied, complex and often non-recurring, requiring staff input, innovative, creative, and Lean diagnostic techniques to resolve issues.
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.
Written Communications: Ability to communicate clearly and effectively in written English with internal and external customers.
Oral Communications: Ability to comprehend and communicate complex verbal information in English to medical center staff, patients, families and external customers.
Knowledge: Ability to demonstrate in-depth knowledge of concepts, practices and policies with the ability to use them in complex varied situations.
Team Work: Ability to lead collaborative teams for larger projects or groups both internal and external to the Medical Center and across functional areas. Results have implications for the management and operations of multiple areas of the organization.
Customer Service: Ability to provide a high level of customer service and staff training to meet customer service standards and expectations for the assigned unit(s). Resolves service issues in the assigned unit(s) in a timely and respectful manner.
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: Exposure to dust, gas, fumes, steam, chemicals.
o Seasonally: Potential exposure to infectious diseases and/or airborne pathogens.
Sensory Requirements:
Close work (paperwork, visual examination), Color vision/perception, Visual monotony, Visual clarity
Physical Requirements:
Light work: Exerting up to 20 pounds of force frequently to move objects. Some elements of the job are sedentary, but the employee will be required to stand for periods of time or move throughout the hospital campus
This job requires constant Keyboard use, frequent sitting, walking, standing, Fine Manipulation using one hand. There may be occasional Pushing/Pulling using both hands
Pay Range:
$0.00 USD - $0.00 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.
As a health care organization, we have a responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities. Beth Israel Lahey Health requires that all staff be vaccinated against influenza (flu) as a condition of employment.
More than 35,000 people working together. Nurses, doctors, technicians, therapists, researchers, teachers and more, making a difference in patients' lives. Your skill and compassion can make us even stronger.
Equal Opportunity Employer/Veterans/Disabled
