Drug Safety Specialist

Details for the position are as follows: 6-month contract to start. Location: Plainsboro, NJ – 100% onsite to start Mon-Fri 8:30a-5:00p (up to 40 hours/week) Rate: $28-31 an hour Job 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 label Call Handling: Manage inbound/outbound calls for adverse events and technical complaints, including refund/replacement requests; handle escalations Data Entry & Quality: Perform data entry and case review; provide feedback to case handlers to ensure high-quality case processing Follow-Up Activities: Manage incoming/outgoing correspondence; collect and document follow-up information Triage & Assignment: Perform case triage, classification, and assignment Training & Support: Assist in training and mentoring new hires Operational Support: Perform reconciliations, workload coordination/distribution, and call monitoring Quality & Compliance: Identify trends, support corrective actions, coordinate database configuration requests, and act as SME during audits/inspections Customer Service: Deliver high-quality service and accurate, timely responses using approved labeling and call scripts Process Improvement: Identify procedural gaps and recommend/implement improvements Projects: Support department-related initiatives Required Skills: Bachelors degree required Healthcare degree required (nursing, pharmacy etc.) Previous drug safety experience required #LI-KJ1 By 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   

Apply Now