Drug Safety Specialist

Details for the position are as follows:6-month contract to start. Location: Plainsboro, NJ - 100% onsite to startMon-Fri 8:30a-5:00p (up to 40 hours/week)Rate: $28-31 an hourJob Description:Responsible for receipt, processing, triage, and quality assessment of all inbound safety information (adverse events and technical complaints). US marketed (drug/device) and investigational products. Ensures compliance with all internal and external (e.g., FDA) safety reporting requirements related to collection and maintenance of safety records.Case Processing & Data Management: Process adverse events and technical complaints (incl. analysis results) in local intake, complaint, and global safety databases: duplicate searches, product coding, MedDRA coding, narrative generation, labeling assessment per approved labelCall Handling: Manage inbound/outbound calls for adverse events and technical complaints, including refund/replacement requests; handle escalationsData Entry & Quality: Perform data entry and case review; provide feedback to case handlers to ensure high-quality case processingFollow-Up Activities: Manage incoming/outgoing correspondence; collect and document follow-up informationTriage & Assignment: Perform case triage, classification, and assignmentTraining & Support: Assist in training and mentoring new hiresOperational Support: Perform reconciliations, workload coordination/distribution, and call monitoringQuality & Compliance: Identify trends, support corrective actions, coordinate database configuration requests, and act as SME during audits/inspectionsCustomer Service: Deliver high-quality service and accurate, timely responses using approved labeling and call scriptsProcess Improvement: Identify procedural gaps and recommend/implement improvementsProjects: Support department-related initiativesRequired Skills:Bachelors degree requiredHealthcare degree required (nursing, pharmacy etc.)Previous drug safety experience requiredBy applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy