Adverse Events and Product Complaints Lead

Description

About Us

At Gifthealth, we're revolutionizing the way people experience healthcare by simplifying the process of managing prescriptions and health services. Our mission is to provide a seamless, personalized, and efficient healthcare experience for all our customers. We're a dynamic, innovative, and customer-centric company dedicated to making a positive impact on people's lives.

Position Summary

We 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 Classification

Status: Full-time
FLSA: Exempt  

Equal Employment Opportunity (EEO) Statement

Gifthealth is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, transgender status, national origin, age, disability, veteran status, or any other legally protected status.  

We celebrate diversity and are committed to creating an inclusive environment for all employees. If you do not meet every requirement but still feel you would be a great fit for this role, we encourage you to apply!

Disclaimer

This job description is intended to describe the general nature and level of work being performed. It is not intended to be an exhaustive list of all responsibilities, duties, or skills required of personnel. Gifthealth reserves the right to modify job duties or descriptions at any time.