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Job Summary:
The Medication Safety Regulatory Compliance Pharmacist is responsible for designing, implementing, and monitoring medication safety programs and ensuring ambulatory pharmacy compliance with state and federal regulations. This role leads proactive and reactive safety initiatives across all but not limited to clinica'based ambulatory care, retail, specialty, maila'order, infusion centers, and pharmacist-led ambulatory services.
Responsibilities:
- Lead the development, implementation, and oversight of ambulatory medication safety programs.
- Conduct roota'cause analyses (RCA), failure mode and effects analyses (FMEA), and event reviews related to medication errors, near misses, or process failures.
- Develop and maintain a standardized medication safety reporting structure for ambulatory care settings.
- Analyze medication event data to identify trends and propose systema'level improvements.
- Serve as subject matter expert for safe prescribing, dispensing, storage, administration, and monitoring of medications across ambulatory workflows.
- Ensure compliance with Board of Pharmacy, DEA, FDA, USP (including USP 795/797 for applicable ambulatory infusion), CMS, HRSA (340B), and state/federal regulations.
- Prepare ambulatory pharmacy operations for regulatory surveys, audits, and accreditation visits (URAC, ACHC, CPPA, or healtha'system accreditation).
- Maintain policies, procedures, and audit tools to ensure consistent regulatory alignment across all sites.
- Conduct routine compliance audits of clinics, retail/specialty pharmacies, and infusion locations.
- Lead corrective action plan development and followa'up following audits or regulatory findings.
- Collaborate with interdisciplinary teams to design and implement higha'reliability medication practices.
- Develop safetya'focused education and training for pharmacists, technicians, medical assistants, and providers.
- Evaluate new technologies (automation tools, ADCs, EPIC/Willow enhancements, dispensing systems) for their impact on medication safety.
Qualifications/Requirements:
Experience:
- 35 years of pharmacy experience in ambulatory, hospital, specialty pharmacy, or related clinical setting.
- Strong working knowledge of pharmacy regulations (state Board of Pharmacy, DEA, FDA).
- Experience with medication safety, quality improvement, or regulatory readiness.
- Proficiency with EHR and pharmacy systems (e.g., EPIC/Willow)
Education: PharmD required; advanced degree (MS, MHA, MBA, or MPH) preferred..
Licenses / Certifications: Current NYS pharmacist license required, or eligible to obtain within 90 days of hire.
Other:
