Pharmacovigilance Specialist I, II, III

Gifthealth•Columbus, OH

6d•Hybrid

About The Position

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 a Pharmacovigilance Specialist I. Reporting to the Adverse Events & Product Complaints (AEPC) Lead, the Pharmacovigilance Specialist I is responsible for the intake, investigation, documentation, and reporting of all Adverse Events (AEs) and Product Complaints (PCs) in accordance with FDA and manufacturer requirements. This role ensures all AEPC cases are fully investigated, accurately documented, and submitted within the required 24-hour reporting timeline. The specialist responds to patient-reported safety concerns, gathers required information, and maintains complete audit-ready records in compliance with Good Documentation Practices (GDP) and regulatory standards. This position plays a key role in supporting the AEPC team, ensuring alignment with organizational goals, operational excellence, and compliance standards.

Requirements

Bachelor’s degree in healthcare management, pharmacy, nursing, life sciences, or related field (required)
Minimum 1-3 years of experience in adverse event reporting, quality, compliance, or regulated healthcare operations (Required)
Working knowledge of call center or intake workflows supporting AE/PC review
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 (Required)
Ability to manage multiple AEPC cases simultaneously while meeting strict deadlines (Required)
Ability to conduct patient-facing investigations with professionalism and empathy (Required)

Nice To Haves

Pharmacovigilance, drug safety, or regulatory compliance training (Preferred)
Experience working with FDA AEPC submissions or manufacturer safety reporting requirements (Preferred)
Experience with QMS systems and safety databases (Preferred)
Knowledge of manufacturer-specific AEPC reporting portals; pharmacovigilance workflows in a pharmacy or healthcare environment (Preferred)
Data tracking and reporting skills (Preferred)
Ability to Identify potential trends or patterns in AEPC data (Preferred)

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