Careers

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

  • Responsible for REGULATORY COMPLIANCE leading to pharmacy management.
  • The Pharmacy Regulatory and Compliance Analyst is responsible for tracking, monitoring, reviewing, interpreting and communicating all aspects of existing, proposed and newly enacted federal and state rules and regulations.
  • Participates in the development of policies and procedures related to applicable pharmacy accreditation standards and compliance with federal and state rules and regulations.
  • Develop company policies and procedures and coordinate with the management to ensure their proper adherence and implementation.
  • Constantly monitor for non-compliance and create action plans for improvement to uphold regulations.
  • Conduct regular audits to ensure compliance with state and federal laws including but not limited to:
  • Health insurance portability and accountability act (HIPAA)
  • Food and drug administration (FDA)
  • Fraud, waste, and abuse (FWA)
  • Centers for Medicare and Medicaid services (CMS)
  • Design and create training manuals to update and improve staff knowledge to reduce noncompliance.
  • Conduct regular meetings to communicate with employees about any upcoming changes to any internal policies and procedures or external laws and regulations to ensure awareness.
  • Oversee and prepare the pharmacy for any external audits and regulatory investigations including but not limited to:
  • Durable medical equipment (DME)
  • Medicare Part D
  • Medicaid and other private insurances
  • Participation in reviewing patient complaints for Medication safety and Patient awareness for Health.
  • Identify opportunities to improve the patient safety program to reduce medication errors.
  • Ensure compliance to adverse drug reporting and documentation within a timely manner.
  • Collaborate with the pharmacist to Conduct Medication therapy management (MTM) services to improve patient adherence to medications and reduces chances of errors.
  • Coordinates and arranges for the receipt of complaint samples and medical records from reporter/complainant/ hospitals, medical facilities/pharmacies, etc.
  • Design and implement workstation protocols for proper prescription data entering and filling to minimize errors.
  • Monitoring, analyzing, interpreting and Communicating regulatory changes by utilizing available resources from regulatory organizations.
  • Job duties including periodical meetings 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.
  • 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 prime Rx system (Electrical’s claim submission vendor) 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. OIG complain 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.
  • Keep updates with new compliance requirements and review the compounding of the prescriptions looking for discrepancies, if any in what being dispenses and the prescription provided by the Physician.
  • Execute the strategic and compliance plans for the company, with particular emphasis on achieving overall profitability with sales and future expansion.
  • To assist the pharmacist to reduce potential of regulatory and compliance dispensing errors.
  • Prepare the protocols and SOPs for regular operations of the pharmacy and keep updated in 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.
  • Addition of new SOPs as per requirements for keep employees in same track to follow the pattern in accordance to the government Regulatory authorities.
  • 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 rule making 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 update 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 substance and the inventory management of control substance consistent with the strategic plan of the company.
  • Assist in maintain the inventory record of CII, CIII, CIV and CV drugs.
  • Oversee the entire pharmacy inventory and ensuring compliance in maintaining schedule 2-5 drug inventory.
  • Collaborate with the pharmacy staff to ensure compliance in situations like drug recalls and outdated drug returns.
  • Implement policies and procedures to reduce drug diversion and ensure compliance in reporting to DEA in case of theft or loss of for schedule drugs.
  • Design protocols to minimize drug diversion.
  • 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 Sciences or Drug Regulatory Affairs.