Complaint and Clinical Pharmacist
Core
Owns complaint investigations for adverse drug events and product quality in a 503A/503B pharmacy, assessing clinical risks and driving corrective actions.
Role type
Senior clinical pharmacist (quality & safety)
Builds
Defensible complaint records, CAPAs, and inspection-ready quality systems
Domain
Healthcare / Pharmaceutical compounding and outsourcing
Required skills
Clinical risk assessment, complaint investigation, CAPA development, regulatory reporting, staff supervision, technical writing
Preferred skills
Compounding experience, inspection preparation, controlled substance account review
Technologies
None stated
Responsibilities
Investigate and document adverse drug event and product quality complaints; Assess clinical impact and escalate serious safety concerns; Trend complaints to identify root causes and recommend CAPAs; Coordinate regulatory reporting and support FDA/state inspections; Supervise assigned staff and provide designated pharmacist coverage
Seniority
Mid-Senior, hands-on IC