Pharmacovigilance Specialist II

Gifthealth Inc • Columbus, OH

13d • Hybrid

About The Position

We are seeking a Pharmacovigilance Specialist II. Reporting to the Adverse Events & Product Complaints (AEPC) Lead, the Pharmacovigilance Specialist II 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 4-7 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)
• 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level