Complaint and Clinical Pharmacist

Empower Pharmacy•Houston, TX

14h•Onsite

About The Position

The Complaint and Clinical Pharmacist protects patient safety and strengthens product quality across Empower’s 503A compounding pharmacy and 503B outsourcing facility operations. The role owns assigned complaint investigations from intake through authorized closure, integrating clinical judgment, evidence gathering, and precise documentation to reach 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 pharmacist supports reporting assessments, technical investigations, controlled substance account reviews, and inspection readiness. Responsibilities also include supervising assigned staff and providing pharmacist coverage only when formally designated and appropriately qualified. The role requires disciplined execution, sound prioritization, confidentiality, and learning agility as operational needs and regulatory expectations evolve.

Requirements

Doctor of Pharmacy degree from an accredited program.
Active pharmacist license in the applicable jurisdiction for assigned responsibilities.
3–5 years of relevant pharmacist experience demonstrating sound clinical judgment, accurate documentation, accountability, and timely issue escalation.
Ability to work onsite, particularly during training, meetings, and inspections, and meet applicable state requirements for formally designated coverage.
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 CAPAs 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.

Nice To Haves

Experience in clinical pharmacy, compounding, complaint investigations, patient safety, or regulated quality systems, including collaboration with quality or regulatory partners.
Experience supervising staff, coordinating investigation priorities, or supporting inspection preparation while maintaining clear documentation and appropriate escalation of unresolved issues.

Responsibilities

Receive, triage, investigate, and document assigned adverse drug event and product quality complaints under approved SOPs, obtaining required approvals before authorized closure.
Gather patient, prescriber, product, lot, distribution, manufacturing, and laboratory information to develop scientifically defensible conclusions and accurate complaint records.
Assess clinical impact and promptly escalate serious adverse events, potential product defects, and patient safety concerns through established channels.
Trend complaints by product, lot, event type, severity, recurrence, and potential root cause; present findings and recommend CAPAs or further investigations.
Provide clinical and pharmaceutical assessments for health hazard evaluations, nonconformances, protocols, stability reviews, and other technical investigations.
Coordinate potential reporting obligations with site pharmacists-in-charge, Regulatory Affairs, and Quality Assurance; support state, DEA, FDA, and internal inspections and responses.
Support reviews of escalated new controlled substance accounts, investigate red flags, and document pharmacist recommendations for authorized approvers.
Support onsite pharmacists-in-charge and provide absence coverage only with formal designation, appropriate qualifications, and compliance with applicable state requirements.
Supervise assigned staff, coordinate work priorities, and assist Quality Assurance with overdue investigations, complaint-related CAPAs, and assigned effectiveness checks.