Drug Safety Specialist I, II, III
About The Position
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.
Requirements
- High school diploma or equivalent (Required)
- Pharmacy Technician Trainee or Licensed Pharmacy Technician or willingness to obtain licensure within required timeframe (Required)
- 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)
- 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)
- Strong investigative and documentation skills (Required)
- Strong attention to detail and accuracy in completing complex process skills (Required)
- 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)
- 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
- Bachelor’s degree in life sciences, healthcare, nursing, pharmacy, or related field (Preferred)
- Pharmacovigilance, drug safety, or quality-related training (Preferred)
- 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 of cold chain handling and temperature excursion management and common human error scenarios in pharmacy operations (e.g., syringe or ancillary supply issues) (Preferred)
- Basic trend analysis and reporting skills (Preferred)
- Ability to identify recurring replacement drivers and contribute to process improvement discussions (Preferred)
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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
Number of Employees
1-10 employees
