Regulatory and Compliance Analyst job BRONX New York
Regulatory and Compliance Analyst  job BRONX New York
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Regulatory and Compliance Analyst Job



Employer Name: Shiv Hari RX Inc. dba Morris Pharmacy SpiderID: 13636910
Location: BRONX, New York Date Posted: 1/2/2024
Wage: Category: Medical/Health
Job Code:

Job Description:

Regulatory and Compliance Analyst is needed to perform the following duties:

o Responsible for REGULATORY COMPLIANCE leading to pharmacy management:
• Leading and coordinating regulatory compliance efforts within scope of responsibility across the Shiv Hari RX Inc Pharmacy.
o Chair the Pharmacy Performance Improvement and Regulatory Compliance requirements
• Evaluating and ensuring departmental and organizational policy and practice compliance with applicable state and federal laws, rules and regulations, including but not limited to,
o Fraud, waste and Abuse (FWA),
o Centers for Medicare & Medicaid Services (CMS),
o Drug Enforcement Agency (DEA),
o Food and Drug Administrations (FDA)
o Health Insurance Portability and Accountability Act (HIPAA),
o Office of Inspector General's (OIG), Prescription drug monitoring program (PDMP),
o Medication therapy management (MTM)
• Review Perspectives monthly in order to meet the FWA requirements of 45 CFR of Part 46 regulated by Office for Human Research Protections (OHRP)
• Complete annual CMS review and go through the policy and manuals for the required changes needed to be implemented to the pharmacy laws and regulation including durable medical equipment (DME including medical devices).
• Ensure biannual licensure renewals and other ongoing required education and/or monitoring for the employees work flow and job duties.
• Develop compliance-related staff education programs and materials upon frequent changes made to the regulatory bodies.
• Coordinating and participating in on-site, virtual, and paper audits as required by regulatory bodies
• Working collaboratively with other pharmacy and organizational departments and managers to plan, coordinate and implement compliance improvement projects and programs for the pharmacy benefit.
• Tracking data and creating reports to assist in the analysis of compliance and safety issues including but not limited to ongoing regulatory monthly inspections, tracers, adverse event reporting, core measures and other accountability measures.

o Participation in reviewing patient complaints for Medication safety and Patient awareness for health.

• Coordination of a consistent and timely approach to medication-related event review and follow-up (in conjunction with the pharmacy patients and providers), under the direction of Medication Safety tips provided by MTM analysis, ensuring accurate documentation of root cause analysis and its Therapy management
• Conducting Medication Therapy Management Program (MTM) and Mirixa healthcare services providing bridge between pharmacy performances and Patient health assessment.


o Monitoring, analyzing, interpreting and communicating regulatory changes by utilizing available resources from regulatory organizations:
• Job duties including periodical meeting with Pharmacy staff and pharmacist to keep tract for ongoing process of the pharmacy operation in order to comply with current regulation requirements
• Prepare the implementation of strategic plan with Gantt chart for the task to perform vs duration of time.

o Provide the required State, Federal, Medicaid and Medicare Laws compliance support and lead in DEA Regulations. Respond to complaints from the state, OIG complains, state inspections, PDMP, DEA Inspection findings, Insurance audit findings and its response.
• Attending the insurance audits and providing them the necessity documents as proof of compliance with regulatory requirements.
• Responding on the audit findings by submitting the missing documents, to justify the claim discrepancies and amount deduction applied to the pharmacy
• Checking the PDMP website prior to dispensing the controlled Rx’s and submission of the claims to the PDMP website through computerized system (electronic claim submission system) on daily bases in order for the regulatory bodies to find discrepancies in claim submission or overuse of opioid medicine by patient.
• Resolve the discrepancies findings responded by PDMP software.
• Handling complaint and inspection by submitting the e-signature logs for Rx’s through the system software, copies of Rx’s required by the auditors and all the regulatory policy and procedure related to the regulations of the Pharmacy


o Prepare the protocols and SOPs for regular operations of the pharmacy and keep updated in a timely manner.

• Prepare SOPs for Starting of the month
• Prepare SOPs for Ending of the month
• Prepare protocol for regular pharmacy operation
• Prepare SOP for Medication delivery operation
• Prepare SOP for checking Prescription Drug monitoring website prior to dispensing the CII Rx’s

o Addition of new SOPs as per pharmacy requirements for keep employees in same track to follow the pattern in accordance to the government regulatory authorities.

o Coordinate with staff to ensure department compliance with policies, procedures, by laws, regulatory requirements, and best practice guidelines; medications as per insurance requirements.
• To coordinate with pharmacy staff and other departments to ensure compliance for regulatory requirements and insurance requirements.
• To coordinate with the pharmacy department to check the guideline of insurance claim submission and checking their formularies to standardize the compliance criteria for compliances.
• To ensure the pharmacy department regarding the prescription filling beyond 30-day supplies with patient insurance and checking the eligibility of the patient and to guide the patient for that.
• To maintain the claim settlement according the insurance guideline
• Especially coordination of clinical department.


o Responsible for medication inventory-the DEA regulations compliance including bringing together the documentation of expired controlled substances and the inventory management of control substances consistent with the strategic plan of the company.
• Assist in maintain the inventory record of CII, CIII, CIV and CV drugs
• Review and assist pharmacists with DEA-106 forms for loss or theft of federal controlled substances.
• Assist the employee in recall medication and its return procedure
• Updating Inventories for regular and controlled medicines every 6 month and assist in returning of the medication through legal way.


Bachelor Degree is required in Pharmacy or Pharmaceutical Science or Pharmaceutics or Drug Regulatory Affairs


Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required: Bachelors
Overnight Travel:
Vacation Time:


Contact Information:
Contact Name: Shiv Hari RX Inc. dba Morris Pharmacy Company Type: Employer
Company: Shiv Hari RX Inc. dba Morris Pharmacy
City: Bronx
State: New York
Zip:

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