Drug Safety Specialist
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. 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. 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. Apply tot his job