Gifthealth · 1 day ago
Adverse Events and Product Complaints Lead
Columbus,OH,US
Full-time
Hybrid
Mid, Senior Level
3+ years expGifthealth is revolutionizing healthcare by simplifying the management of prescriptions and health services. The Adverse Events and Product Complaints Lead oversees all adverse event and product complaint processes for the pharmacy, ensuring compliance and timely submissions while leading a small team to monitor and report on safety and regulatory standards.
Health CarePharmaceuticalSoftware
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
Qualification
Required
Bachelor's degree in pharmacy, nursing, life sciences, or related field
Minimum 3 years of experience in adverse event reporting, pharmacovigilance, or product complaint management
AE/PC management within a regulated healthcare or pharmaceutical setting
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
Strong organizational, leadership, and analytical skills
Excellent written and verbal communication
Proficiency in documentation management and QMS systems
Ability to lead and train drug safety team to meet strict submission SLAs
Ability to communicate effectively with manufacturers and regulatory agencies
Ability to manage competing deadlines with precision and urgency
Preferred
Certified Drug Safety Associate or equivalent pharmacovigilance certification
Supervisory or scheduling responsibilities within compliance or quality teams
Experience with reconciliation or QMS systems used for safety documentation
Prior voice analytics and call center experience
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
Experience trending and analyzing AE/PC data for pattern recognition
Familiarity with Zendesk, Salesforce, or other ticketing/call center systems
Ability to develop AEPC dashboards and reconciliation reports for leadership visibility
Company
Gifthealth
GiftHealth is a healthcare tech startup that streamlines pharmacy experience with free delivery and competitive medication pricing.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
$45.8MKey Investors
Eir PartnersAllos Ventures
2023-04-04Private Equity· $40M
2021-03-16Seed· $5.8M
2020-06-04Pre Seed
Leadership Team
John Romano
President and Co-Founder
Derek Schneider
CTO
Recent News
2026-01-14
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