Job Description
Regulatory and Compliance Analyst is needed to perform the following duties:
EDUCATIONAL REQUIREMENTS: BACHELORS DEGREE IS REQUIRED IN PHARMACY OR DRUG REGULATORY AFFAIRS OR PHARMACEUTICAL SCIENCE OR PHARMACOLOGY/TOXICOLOGY
Regulatory Interpretation and compliance oversight
Monitor compliance with FDA, DEA and HIPPA and state board pharmacy to ensure full compliance across the pharmacy operations.
Ensure proper handling of controlled substances, hazardous drugs.
Work with pharmacist in investigating and reporting medication errors and adverse drug events
Maintain accurate documentation for pharmacy inspections
Controlled Substance Monitoring & DEA Compliance
Administer comprehensive oversight of controlled substance management, including accurate inventory reconciliation, procurement tracking, dispensing documentation, and secure storage protocols for Schedule II V medications,
Ensure adherence to DEA regulations and reporting requirements.
Internal Audits & Risk Assessment
Conduct compliance audits of dispensing, controlled substances, and patient safety practices to meet DEA, FDA, state Board, and HIPAA requirements.
Analyzing medication errors and workflow gaps to prioritize risks and develop CAPA plans.
Monitored CAPA actions with staff, improving compliance and reducing repeat audit findings.
Drug Utilization Review
(DUR) Compliance
Evaluate the prescriptions for appropriateness, dosing, and duplication
Identifying drug interactions, contraindications, and toxicity risks, especially in high-risk populations.
Review controlled substances for appropriate use and potential misuse or diversion.
Resolving DUR alerts with prescribers and staff, improving medication safety and regulatory compliance.
Medication Therapy Management (MTM) Oversight
Audit MTM documentation to ensure compliance with CMS, state board, and internal pharmacy regulations.
Verify completeness of CMRs and TMRs, including consent, care plans, interventions, and follow-ups.
Ensure documentation supports accurate billing, reimbursement, and audit readiness in the pharmacy.
Identify documentation gaps and implement corrective actions such as staff retraining or workflow improvements.
Stay updated on regulatory changes and revise internal MTM documentation protocols accordingly.
Drug Recall Management and Clinical Documentation Auditing
Execute FDA-compliant drug recall processes, including identification, quarantine, and removal of affected products from inventory. Communicate with pharmacist and pharmacy staff about recall alerts and ensure timely patient notification when required, with complete documentation of actions taken.
Maintain accurate recall records (lot numbers, distribution tracking, and resolution status) to ensure audit and inspection readiness.
Coordinate with wholesalers, manufacturers, and internal teams for return, replacement, or proper disposal of recalled medications while supporting process improvement initiatives.
Review patient records for regulatory and clinical accuracy.
Hazardous Drug, Data Analysis & Environmental Compliance Reporting.
Analyze pharmacy data and generate compliance reports.
Ensure safe handling and disposal of hazardous medications.
Pharmacovigilance & Adverse Event Reporting
Monitor and report adverse drug events.
Maintain compliance with drug safety reporting systems. Ensure accurate documentation and adherence to pharmacovigilance protocols, supporting regulatory compliance and data integrity in drug safety reporting.
Ensure compliance with State, Federal, Medicaid, and Medicare regulations; support DEA requirements, including documentation and disposal of expired controlled substances and accurate inventory management, aligned with the companys strategic plan.
Maintain strict compliance with HIPAA regulations, ensure timely updates; manage OIG screening for employees and vendors and report any exclusions.
Conduct monthly reviews to ensure adherence to Fraud, Waste, and Abuse (FWA) requirements under 45 CFR Part 46, as regulated by OHRP. Ensure ongoing compliance with DEA, CMS, New York State Board of Pharmacy, and all applicable state and federal regulations.
Keep Standard Operating Procedures (SOPs) current for prescription processing, medication storage, temperature monitoring logs, daily operations, and controlled substance management.
Assist in pharmacy billing and reimbursement operations; support internal audit activities and quality assurance compliance efforts
Ensure correct NDC, reviewing prior authorizations and copay calculations. Processing claims through insurance systems, including Medicare part d, Medicaid and other private insurances.
Review billing records and documentation accuracy. Identify patterns of errors and compliance gaps. Conduct prescription audits, inventory audits and controlled substance audits.
Resolve claim rejections, insurance discrepancies. Prepare for external audits from insurance companies and government agencies.