Position SummaryWe are seeking an Adverse Events and Product Complaint (AEPC) Lead. Reporting to the Director of Pharmacy Quality & Compliance, the AEPC Lead oversees all adverse event and product complaint processes for the pharmacy, ensuring accurate documentation, timely submission, and full compliance with manufacturer and regulatory expectations. This role ensures all AE/PC cases are reviewed and submitted to our client(s) within the required timeframes. This position leads a small team of AEPC staff, coordinates with call center operations, and ensures AEPC records are properly entered and reconciled in the Quality Management System (QMS). The AEPC Lead identifies trends, escalates findings to the appropriate governing bodies, and upholds patient safety and regulatory integrity through continuous monitoring and reporting.
This position plays a key role in supporting the AEPC team, ensuring alignment with organizational goals, operational excellence, and compliance standards.
Key Responsibilities- Oversees the intake, documentation, and submission of all Adverse Events and Product Complaints to the client within 24-hour SLA requirements.
- Completes monthly AEPC reconciliation with the client, ensuring all reports are logged, matched, and closed within compliance parameters
- Maintains and update AEPC tracking and trending reports to identify recurring product or safety concerns; escalate trends to appropriate governing bodies.
- Reviews and audit all AEPC tickets from the call center to ensure submissions are timely, accurate, and properly documented.
- Schedules and leads AEPC team operations, ensuring coverage, adherence to SLAs, and accuracy in workload management.
- Ensures all AEPC documentation is entered and maintained within the Quality Management System (QMS) for audit readiness and compliance traceability.
- Serves as liaison between Gifthealth, the client, and compliance partners for all AEPC-related communication, training, and process improvement initiatives.
- Supports compliance audits, ensuring all AEPC data and QMS records meet regulatory and manufacturer expectations.
Qualifications- Education: Bachelor's degree in pharmacy, nursing, life sciences, or related field (required)
- Licensure/Certification: Certified Drug Safety Associate or equivalent pharmacovigilance certification (Preferred)
- Experience:
- Minimum 3 years of experience in adverse event reporting, pharmacovigilance, or product complaint management (Required)
- AE/PC management within a regulated healthcare or pharmaceutical setting (Required)
- Supervisory or scheduling responsibilities within compliance or quality teams (Preferred)
- Experience with reconciliation or QMS systems used for safety documentation (Preferred)
- Prior voice analytics and call center experience (Preferred)
- Knowledge, Skills & Abilities:
- Working knowledge of call center or intake workflows supporting AE/PC review
- Knowledge of FDA AE/PC reporting requirements (21 CFR Parts 7, 211, 314.80, 600.80); Good Documentation Practices (GDP) and ALCOA principles; Call center workflows related to AEPC ticket triage; and QMS platforms and pharmacovigilance reporting systems (Required)
- Knowledge of client's AE/PC systems and reconciliation procedures; ICH E2A and E2D guidelines for clinical safety data management; and ISO 13485 and post-market surveillance concepts (Preferred)
- Strong organizational, leadership, and analytical skills (Required)
- Excellent written and verbal communication (Required)
- Proficiency in documentation management and QMS systems (Required)
- Experience trending and analyzing AE/PC data for pattern recognition (Preferred)
- Familiarity with Zendesk, Salesforce, or other ticketing/call center systems (Preferred)
- Ability to lead and train drug safety team to meet strict submission SLAs (Required)
- Ability to communicate effectively with manufacturers and regulatory agencies (Required)
- Ability to manage competing deadlines with precision and urgency (Required)
- Ability to develop AEPC dashboards and reconciliation reports for leadership visibility (Preferred)
Work Environment- Location: Hybrid/On-site
- Schedule: Monday through Friday
- May require availability during peak periods or flexibility for escalations.
- Regular meetings with internal Compliance, Quality Assurance, Pharmacy Operations, and Call Center Teams. This role also interacts with client(s), the Food and Drug Administration (FDA) and other regulatory entities as needed.
Key Essential Functions- Must be able to stand for at least 4 hours at a time while working
- Must be able to lift up to 25 pounds with or without assistance.
- Must perform repetitive motions for an entire shift: bending, reaching, lifting, scanning.
- Must be able to work onsite for all shifts.
Employment ClassificationStatus: Full-time
FLSA: Exempt
Salary Description
$84,000-$100,000
