Gifthealth · 16 hours ago
Pharmacovigilance Specialist II
Columbus,OH,US
Full-time
Hybrid
Mid, Senior Level
4+ years expGifthealth is a dynamic and innovative company revolutionizing healthcare by simplifying prescription and health service management. The Pharmacovigilance Specialist II is responsible for the intake, investigation, documentation, and reporting of Adverse Events and Product Complaints, ensuring compliance with FDA and manufacturer requirements.
HealthcareSoftwarePharmaceuticalHealth Care
Responsibilities
Completes intake, document, and submit all Adverse Events and Product Complaints within 24-hour FDA and manufacturer SLA requirements
Investigates patient-reported events by gathering complete and accurate information in accordance with regulatory guidelines
Maintains AEPC documentation in QMS systems ensuring accuracy, traceability, and audit readiness
Validates AEPC case completeness, including timelines, product details, and patient outcomes
Communicates appropriately with patients and internal teams regarding AEPC investigations and next steps
Supports AEPC trend analysis and reporting as directed by AEPC Lead
Supports internal and external audits related to AEPC reporting
Qualification
Required
Bachelor's degree in healthcare management, pharmacy, nursing, life sciences, or related field
Minimum 4-7 years of experience in adverse event reporting, quality, compliance, or regulated healthcare operations
Knowledge of FDA AE/PC reporting requirements; 21 CFR Part 314.80 and FDA post-marketing safety reporting standards; Good Documentation Practices (GDP) and ALCOA principles; AEPC investigation and case documentation standards
Ability to manage multiple AEPC cases simultaneously while meeting strict deadlines
Ability to conduct patient-facing investigations with professionalism and empathy
Preferred
Pharmacovigilance, drug safety, or regulatory compliance training
Experience working with FDA AEPC submissions or manufacturer safety reporting requirements
Experience with QMS systems and safety databases
Knowledge of manufacturer-specific AEPC reporting portals; pharmacovigilance workflows in a pharmacy or healthcare environment
Data tracking and reporting skills
Ability to Identify potential trends or patterns in AEPC data
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
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-01-13
2026-01-11
Company data provided by crunchbase