Pharmacovigilance Specialist II at Gifthealth

Columbus, Ohio, United States -

Full Time

Start Date

Immediate

Expiry Date

14 May, 26

Salary

86138.0

Posted On

13 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Adverse Event Reporting, Product Complaints, FDA Compliance, Case Documentation, Regulatory Guidelines, QMS Systems, Audit Readiness, Data Tracking, Patient Communication, Trend Analysis, Good Documentation Practices, ALCOA Principles, Case Investigation, Safety Databases, Time Management, Empathy

Industry

technology;Information and Internet

Description

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 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. Key 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 Qualifications Education: Bachelor’s degree in healthcare management, pharmacy, nursing, life sciences, or related field (required) Pharmacovigilance, drug safety, or regulatory compliance training (Preferred) Licensure/Certification: None Experience: Minimum 4-7 years of experience in adverse event reporting, quality, compliance, or regulated healthcare operations (Required) Experience working with FDA AEPC submissions or manufacturer safety reporting requirements (Preferred) Experience with QMS systems and safety databases (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 Part 314.80 and FDA post-marketing safety reporting standards; Good Documentation Practices (GDP) and ALCOA principles; AEPC investigation and case documentation standards (Required) Knowledge of manufacturer-specific AEPC reporting portals; pharmacovigilance workflows in a pharmacy or healthcare environment (Preferred) Data tracking and reporting skills (Preferred) Ability to manage multiple AEPC cases simultaneously while meeting strict deadlines (Required) Ability to conduct patient-facing investigations with professionalism and empathy (Required) Ability to Identify potential trends or patterns in AEPC data (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, Call Center and Patient Support teams. This role will also interact with pharmaceutical manufacturers as directed by leadership and regulatory bodies as determined by business needs. 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.

Responsibilities

The Pharmacovigilance Specialist II is responsible for the intake, investigation, documentation, and reporting of all Adverse Events (AEs) and Product Complaints (PCs) within strict 24-hour FDA and manufacturer timelines. This role ensures all cases are fully investigated, accurately documented, and maintained in compliance with Good Documentation Practices (GDP) and regulatory standards.