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

Requirement:

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

*Job Duties:*

• Responsible for REGULATORY COMPLIANCE leading to pharmacy management.
• Responsible for ensuring that departmental and organizational policies and practices comply with applicable state and federal laws, rules, and regulations, including but not limited to Fraud, Waste and Abuse (FWA), Centers for Medicare & Medicaid Services (CMS), Drug Enforcement Agency (DEA), Food and Drug Administrations (FDA), Health Insurance Portability and Accountability Act (HIPAA), Office of Inspector General’s (OIG), Prescription drug monitoring program (PDMP), Medication therapy management (MTM), Mirixa management, and Patient Compliance.
• Review Perspectives monthly to meet the FWA requirements of 45 CFR of Part 46 regulated by the Office for Human Research Protections (OHRP).
• Complete annual CMS reviews 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’ workflow and job duties.
• Develop compliance-related staff education programs and materials upon frequent changes made to the regulatory bodies.
• Co-ordinate and participate in on-site, virtual, and paper audits as required by regulatory bodies.
• Work collaboratively with other pharmacy and organizational departments and managers to plan, coordinate, and implement compliance improvement projects and programs for the pharmacy benefit.
• Track data and create 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.
• 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.
• Monitoring, analyzing, interpreting and communicating regulatory changes by utilizing available resources from regulatory organizations:
• Job duties include periodical meetings with Pharmacy staff and pharmacists to keep track of the ongoing process of the pharmacy operation in order to comply with current regulation requirements.
• Prepare the implementation of a strategic plan with Gantt chart for the task to perform vs duration of time.
• Provide the required State, Federal, Medicaid and Medicare Laws compliance support and lead in DEA Regulations. Respond to complaints from the state, OIG compliance, 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 to 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 prime Rx system (Electricals claim submission vendor) on daily bases in order for the regulatory bodies to find discrepancies in claim submission or overuse of opioid medicine by patients.
• Resolve the discrepancies findings responded to by PDMP software.
• OIG complaint handling, state inspection handling by submitting current employee’s information including HIPAA and FWA certification, employee criminal background checking, Technician Protocol submission, OIG exclusion verification page, 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.
• Ensuring WIC compliance and handling any audits relate to it. Managing OTC network, credit card and Gift card compliances.
• Managing SNP portal and CIR vaccine network to ensure compliances and data management.
• 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 Eyecon pill counter machine with its data transfer info and automatic update instruction
• Prepare SOP for Medication delivery operation
• Prepare SOP for checking Prescription Drug monitoring website prior to dispensing the CII Rx’s
• Lead the research of the pharmacy department through Development of automated processes and reporting, targeted to improve efficiency and ensure compliance of health plan policy/procedures and regulatory standards.
• Monitors regulatory activity and rulemaking through weekly interaction with NACDS, FMI, and state organizations
• Online subscription of government regulated bodies including Medicare, Medicaid, State Federal, DEA, HIPAA and FWA newsletter etc. in order to get automatic updates regarding the new law implementation or change in any existing laws and regulations.
• Coordinating creation and updates of Department of Pharmacy policies & procedures
• Ensure timely signature and posting to intranet page
• Business continuity disaster recovery
• 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 months and assisting in returning of the medication through legal way.