Drug Safety Specialist I, II, III

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 The Drug Safety Specialist I, II, & III – Product Replacement is responsible for the intake, investigation, documentation, and execution of medication replacement events resulting from product integrity issues, logistical failures, or human error scenarios, including syringe defects, incorrect ancillary supplies, administration errors, and dispensing-related mistakes. This role follows established drug safety and replacement workflows under licensed pharmacist oversight and ensures all replacement activities comply with Board of Pharmacy regulations and internal SOPs. The specialist applies pharmacovigilance-style investigation skills to ensure accurate documentation, timely resolution, and audit-ready records while supporting patient safety and continuity of care. We are seeking a Drug Safety Specialist I, II, or III to support our Drug Safety Team. This position plays a key role in supporting our drug safety operations, ensuring alignment with organizational goals, operational excellence, and compliance standards. Key Responsibilities Completes intake and investigates replacement-eligible events, including RTS, temperature excursions, damaged product, incorrect shipments, and human error events (e.g., syringe defects, administration, or dispensing errors) Executes approved medication replacement workflows in accordance with SOPs and pharmacist direction Documents all replacement activities accurately, including investigation details and root cause categorization Validates replacement eligibility information and escalate clinical or regulatory questions to the pharmacist Maintains replacement tracking logs and ensure data accuracy Supports trend tracking and reporting related to replacement drivers Supports audits and inspections related to replacement operations Qualifications Education : High school diploma or equivalent (Required) Bachelor’s degree in life sciences, healthcare, nursing, pharmacy, or related field (Preferred) Pharmacovigilance, drug safety, or quality-related training (Preferred) Licensure/Certification : Pharmacy Technician Trainee or Licensed Pharmacy Technician or willingness to obtain licensure within required timeframe (Required) Experience : Drug Safety I through III requires anywhere between 1–8 years of experience in pharmacy operations, fulfillment, patient support, or drug safety-related roles (Required) Experience investigating medication issues, patient-reported concerns, or operational errors (Preferred for a Drug Safety I and required for a Drug Safety III). Experience in regulated pharmacy, healthcare, or life sciences environments (Preferred for a Drug Safety I and required for a Drug Safety III) Experience with pharmacy systems, ticketing platforms, or safety case tracking tools (Preferred for a Drug Safety I and required for a Drug Safety III) Knowledge, Skills, & Abilities : Knowledge of drug safety and medication replacement workflows; board of pharmacy regulations related to dispensing errors and product integrity; Good Documentation Practices (GDP) and data integrity standards; and pharmacovigilance-style case intake and investigation principles (Required) Knowledge of cold chain handling and temperature excursion management and common human error scenarios in pharmacy operations (e.g., syringe or ancillary supply issues) (Preferred) Strong investigative and documentation skills (Required) Strong attention to detail and accuracy in completing complex process skills (Required) Basic trend analysis and reporting skills (Preferred) Ability to gather complete case details and assess replacement eligibility criteria (Required) Ability to manage multiple replacement cases concurrently while meeting turnaround expectations (Required) Ability to escalate appropriately to pharmacist leadership when clinical judgment is required (Required) Ability to identify recurring replacement drivers and contribute to process improvement discussions (Preferred) Work Environment Location : Hybrid 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: Non-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. #J-18808-Ljbffr