Pharmacy Compliance Auditor

Job description:

We are looking for a Pharmacy Compliance Auditor to perform a variety of pharmacy compliance reviews. The Pharmacy Compliance Auditor is responsible for conducting comprehensive audits and compliance reviews across all entities participating in a Risk Evaluation and Mitigation Strategy (REMS) program. This role ensures that all stakeholders—including manufacturers, prescribers, pharmacies, distributors, and patients—are adhering to FDA-mandated REMS requirements designed to mitigate serious risks associated with specific medications.

The auditor will assess training, certification, restricted distribution processes, patient monitoring, and documentation accuracy to verify that the REMS program is effectively protecting patient safety and meeting regulatory objectives.

Responsibilities

• Audit Execution: Plan, conduct, and document REMS stakeholder audits (manufacturers, pharmacies, prescribers, distributors, and patient) to ensure alignment with FDA-approved REMS elements.
• Verification: Confirm compliance with Elements to Assure Safe Use (ETASU), including prescriber/pharmacy certification, restricted distribution systems, patient enrollment requirements, and monitoring procedures.
• Documentation Review: Evaluate training records, dispensing logs, lab or monitoring results, and adverse event reports for completeness and accuracy.
• Corrective Actions: Identify compliance gaps and recommend corrective and preventive actions (CAPA) to stakeholders. Monitor follow-up until resolution.
• Communication Plans: Verify that required risk communication materials (e.g., prescribing guides, patient brochures, communication letters) are properly distributed and implemented.
• Reporting: Prepare detailed audit findings and risk summaries
• Continuous Improvement: Contribute to development or refinement of internal auditing tools, checklists, and quality standards to strengthen REMS performance.
• Stakeholder Training: Support training programs for internal or external stakeholders based on observed compliance challenges.

Skills

• Strong understanding of risk minimization strategies and regulatory compliance principles.
• Excellent analytical, documentation, and report-writing capabilities.
• Ability to interpret complex safety and regulatory data and communicate findings clearly.
• Proficiency in Microsoft Office or audit management software.
• Attention to details, accuracy and quality
• Sound judgement and decision-making ability
• Strong organizational skills

Qualifications

• 3+ years of experience in pharmaceutical compliance auditing, REMS program management, pharmacovigilance, or regulatory affairs.
• Familiarity with FDA REMS requirements
• Prior experience auditing healthcare providers, pharmacies, or specialty distributors preferred.
• Pharmacy Technician preferred

Key Competencies

• Attention to detail and strong critical thinking.
• Independent judgment and professional integrity.
• Ability to manage multiple audits and stakeholders simultaneously.
• Strong written and verbal communication skills.
• Commitment to upholding patient safety and regulatory compliance.

Ideal candidates must be able to work independently, be self-motivated, have good organizational skills and excellent customer service skills. Ability to identify issues, investigate matters and creatively work to resolve unexpected and unanticipated problems.

Job Type: Full-time

Pay: $55,000.00 - $60,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location: Remote