Drug Safety Specialist

Gifthealth•Columbus, OH

16d•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 The Drug Safety Specialist will play a critical role in ensuring patient safety and regulatory compliance by triaging, documenting, and escalating Adverse Events (AEs) and Product Complaints (PCs) related to pharmaceutical therapies. This is a hybrid position, and candidates will be expected to dedicate 2-3 days per week in the office in Columbus, Ohio.

Requirements

A minimum of two to four years of pharmacovigilance and/or clinical trial experience is required.
If no pharmacovigilance or clinical trial experience, a medical degree (RN, PharmD, etc) with four to five years of clinical experience is required.
Knowledge of pharmacovigilance regulations (CFR/GVP), ICH Guidelines and/or Good Clinical Practices (GCP).
HIPAA compliant - handle confidential and sensitive information with discretion.
Capable of discussing adverse events and complaints in a patient-facing setting.
Experience in generating monthly safety reports and performing reconciliation.
Meticulous attention to detail and the maintenance of precise documentation pertaining to safety data and related activities are required.
Proactive, hardworking, and always willing to take on new tasks.
Must be able to sit and/or work at a computer for extended periods of time.
Must be able to use standard office equipment, including a computer, keyboard, mouse, and telephone.
Must be able to perform repetitive motions throughout the workday, including typing, reading, and reviewing documentation.
Must be able to communicate effectively with internal and external stakeholders in person, via video conference, and in writing.
Must be able to work during standard business hours.

Responsibilities

Monitor and evaluate safety data from multiple sources.
Work with teams to manage product safety data.
Improve internal drug safety processes.
Support the product replacement process.
Complete Adverse Event and or Product Complaint Documentation
Follow company values and promote product safety compliance.
Processing and oversight of adverse event/drug experience reports (serious and non-serious) and other safety related data.
Support investigations and evaluations of adverse events, including reviewing pharmacy records and collaborating with cross-functional teams.
Stay up-to-date with current drug safety regulations and guidelines.
Engage with patients regarding adverse event and complaint details, then accurately complete all required documentation.
Address patient concerns regarding drug product shipment through temperature assessments.
Review and approve product replacement, as required.
Apply clinical and regulatory knowledge to assess risk and determine appropriate escalation paths for adverse event reports.
Play a key role in ensuring organizational compliance with FDA pharmacovigilance regulations and preventing regulatory risk.
Independently evaluate the severity of patient-reported issues in alignment with internal SOPs and federal guidelines.
Ensure compliance with internal procedures, regulatory requirements, and partner agreements to ensure inspection readiness at all times.