Complaint and Clinical Pharmacist

POSITION SUMMARY:

The Complaint and Clinical Pharmacist protects patient safety and strengthens product quality across Empower’s rapidly growing, highly regulated 503A compounding pharmacy and 503B outsourcing facility operations. This role owns assigned complaint investigations from intake through authorized closure, integrating clinical judgment, evidence gathering, and precise documentation to deliver defensible conclusions within procedural timelines. The pharmacist evaluates clinical risks, escalates safety concerns, and translates complaint trends into recommendations for corrective and preventive actions (CAPAs). Working with site pharmacists-in-charge, Quality Assurance, and Regulatory Affairs, the role supports reporting assessments, technical investigations, controlled substance account reviews, and inspection readiness. Responsibilities include supervising assigned staff and providing formally designated pharmacist coverage. Success requires disciplined execution, sound prioritization, confidentiality, and learning agility to sustain reliable outcomes at increasing scale as operational needs and regulatory expectations evolve.

RESPONSIBILITIES:

Complaint Investigation and Patient Safety

• Complaint Ownership: Receive, triage, investigate, and document assigned adverse drug event and product quality complaints under approved SOPs, obtaining required approvals before authorized closure.
• Investigation Evidence: Gather patient, prescriber, product, lot, distribution, manufacturing, and laboratory information to develop scientifically defensible conclusions and accurate complaint records.
• Clinical Assessment: Assess clinical impact and promptly escalate serious adverse events, potential product defects, and patient safety concerns through established channels.

Quality Improvement and Regulatory Support

• Complaint Trending: Trend complaints by product, lot, event type, severity, recurrence, and potential root cause; present findings and recommend CAPAs or further investigations.
• Technical Investigations: Provide clinical and pharmaceutical assessments for health hazard evaluations, nonconformances, protocols, stability reviews, and other technical investigations.
• Regulatory Coordination: Coordinate potential reporting obligations with site pharmacists-in-charge, Regulatory Affairs, and Quality Assurance; support state, DEA, FDA, and internal inspections and responses.

Pharmacy Operations and Team Support

• Controlled Substances: Support reviews of escalated new controlled substance accounts, investigate red flags, and document pharmacist recommendations for authorized approvers.
• Pharmacist Coverage: Support onsite pharmacists-in-charge and provide absence coverage only with formal designation, appropriate qualifications, and compliance with applicable state requirements.
• Staff Coordination: Supervise assigned staff, coordinate work priorities, and assist Quality Assurance with overdue investigations, complaint-related corrective and preventive actions, and assigned effectiveness checks.

KNOWLEDGE AND SKILLS:

• Knowledge of adverse drug event assessment, product quality complaints, clinical risk evaluation, and evidence requirements for scientifically defensible investigations.
• Ability to analyze complaint trends, identify recurring risks, and recommend corrective and preventive actions supported by documented investigation findings.
• Strong technical writing and communication skills for clear complaint records, clinical assessments, inspection responses, and timely escalation of patient safety concerns.
• Ability to coordinate staff and cross-functional priorities, protect confidential information, and apply sound judgment within approved procedures and authorization boundaries.

EXPERIENCE AND QUALIFICATIONS:

• Doctor of Pharmacy degree from an accredited program required.
• An active pharmacist license in the applicable jurisdiction for assigned responsibilities required.
• 3-5 years of relevant pharmacist experience demonstrating sound clinical judgment, accurate documentation, accountability, and timely issue escalation required.
• Ability to work onsite, particularly during training, meetings, and inspections, and meet applicable state requirements for formally designated coverage required.
• Experience in clinical pharmacy, compounding, complaint investigations, patient safety, or regulated quality systems, including collaboration with quality or regulatory partners preferred.
• Experience supervising staff, coordinating investigation priorities, or supporting inspection preparation while maintaining clear documentation and appropriate escalation of unresolved issues preferred.