• info@justinpharmacy.com
  • (212) 923-6111
Compounding Pharmacy Company New York

Justin Pharmacy is looking for Regulatory and Compliance Analyst

Date: 04/05/21

Regulatory and compliance Analyst is needed to Perform the Following duties:

To assure overall regulatory compliance promoting continuous improvement in our internal audit process and risk assessment.

• Drafted policy and procedure (P&P) that needs to be followed for the pharmacy to perform internal audit and achieve regulatory compliance.

• Ensured all pharmacy employees successfully complete training program and execute policies written in the P&P manual.

• Filed, documented, and kept record of all controlled and non-controlled prescriptions.

• Reviewed prescriptions, invoices, claim transaction records, signature logs, purchase record and prices.

• Created report to discover possible therapeutic abuse or illegal activity by the patient.

• Recorded and maintained on file the annual inventory log of controlled substances.

To help pharmacist keep continuous process update with new compliance initiatives.

• Ensured that pharmacy is compliant with all legal, regulatory, statutory, and other requirements set forth by the State and Federal governments.

• Ensured that records and licenses related to pharmacy are up to date and properly displayed. Verifying the professional license of floater or relief pharmacist.

• Monitored and documented current as well as future employees for disbarment or exclusion from participation in programs receiving government funding.

• Implemented fraud, waste, and abuse (FWA) education module. To carry out discreet investigation and act on any reports on potential fraud or misconduct.

• Support the pharmacist to develop new compliance initiatives like monitoring & analyzing the prescription data, evaluate the impact on health/disease outcomes as per the NPC (national pharmaceutical council) for specific health conditions like cholesterol, blood pressure, cardiovascular disease, congestive heart failure, chronic pulmonary heart disease, and depression etc.

• Follow CDC Board (Center of Disease Control) guidelines and news to update any changes in Immunization methods of practice.

• Assist the pharmacist in business operations in involving inventory control, drug utilization review and patient care management, pricing reconciliation review and assist with network prices reporting and monitoring.

• Monitor patient’s medication records and send reminders to patients for the Medication Therapy Management and make sure they stick to their 30 or 90 days Maintenance medications.

• Assist the pharmacist in dispensing by effectively monitoring the data entry, electronic data transfer, processing claims, and inventory maintenance.

To support the research component of the pharmacy department through development of automated processes and reporting, to improve efficiency and ensure compliance of health plan policy/procedures and regulatory standards.

• Researched State laws to identify any regulations that should be added to the pharmacy policy manual and ensure that all policies and procedures are in accordance to State law.

• Researched pharmaceutical regulations and interpret regulatory requirements to implement comprehensive pharmaceutical compliance mechanism.

• Analyzed the data of prescribing patterns of healthcare providers.

• Researched on the latest trends in new pharmaceutical needs, instrumentation technology in pharmacy growth and new regulations for the pharmacy.

• Researched pharmaceutical literature for preparing information materials for the company’s newsletter.

To develop operating procedures to ensure corrective and preventive action.

• To review P&P related to any violation and to undertake corrective action to eliminate the cause of non-conformity to prevent recurrence of violation.

• To make necessary changes to P&P if a violation is attributable to a faulty or unclear policy or procedure.

• To draft a new procedure as a preventive action to eliminate the cause of a potential non-conformity and discuss with the staff to avoid similar violations in future.

• Develop quality assurance techniques to ensure safe and ethical practices efficient inventory control system.

• Evaluate the pharmacy literature and information regarding the use of non-prescription drugs and research within the field of generic and private label merchandise.

• To prevent and reduce Fraud, Waste and Abuse (FWA) by ensuring that all policy and procedure Manual is up to date, accurate and to be sure that the information is passed on to all employees in a timely fashion.

Provide the required State, Federal, Medicaid and Medicare laws compliance support and assist in 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.

• Translate state and federal regulations into business requirements to ensure platform compliance.

• Carry day to day operations of the pharmacy, personnel and record keeping as per guidelines of State and Federal laws.

• Compile and communicate regulatory information to pharmacy employees and ensure that information is interpreted correctly.

• Identify and track compliance issues that require follow-up or investigation.

• Responsible for support of regulatory compliance, clinical and accreditation activities.

Assist in the internal audit of our overrides, billing over-dues, coordinating the diagnostic codes entered in the system regarding use of prescription and non-prescription drugs.

• Discuss billing procedures with staff to verify correctness of the submitted claims for drugs commonly submitted with improper billing units. Provide staff members with job aids associated with common types of quantity and/or days’ supply miscalculations.

• Check for correct prescriber IDs such as NPI or DEA on controlled or non-controlled medication prescriptions. • Verify written prescriptions are on tamper resistant pads and contain all 3 tamper resistant features.

• Verify prescription for correct drug name, strength, direction, DAW codes, date written, prescriber name and associated NPI/DEA and to make sure all state and federal prescription requirements are met. • Help uncover unnecessary costs to the insurance system by taking a close look at billing practices that include billing units, refill practices, overrides, partial fill procedures, package size selection, and proof of delivery documentation. If the following self-audit steps reveal potential overpayments, the self-audit guidelines explain steps that have to be followed.

• Review the rejected claims and billing procedures and follow up the insurance companies for the reimbursements. Involve in the procedures of review of third-party audit, monitoring drug recall and product recall.

• Making sure all overpayments will be refunded to the appropriate third - Party plan, Medicaid, or CMS program within 60 days as required by the Patient Protection and Affordable Care Act of 2010.

• Manage interaction with New York State Board of Pharmacy and Medicare and Medicaid to complete external regulatory audits. • Report any potential fraud or misconduct when appropriate to applicable third-party payers, Medicaid Inspector General or CMS, its designee and/or law enforcement in accordance with applicable state or Federal regulation.

• A drug recall is the most effective way to protect the public from a defective or potentially harmful product. A recall is a voluntary action taken by a company at any time to remove a defective drug product from the market.

• Ensure all drug recall should be done periodically. Recall means a firm’s removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action.

Bachelor’s degree is required in Pharmacy or Drug Regulatory Affairs or Pharmaceutical Science or Regulatory Affairs


Job Loc: 3860 Broadway New York, NY-10032

please email resume to justinpharmacy@gmail.com



ADDRESS

St. Anthony Pharmacy
Justin Pharmacy, INC
3860 BROADWAY
NEWYORK,NY 10032

CONTACT

P: (212) 923-6111
Email: info@justinpharmacy.com
Fax: 2129232882, 6469304777