Drug Safety Associate

Summary:

• Shift hours: 8am to 4pm or 9am to 5pm Mon-Fri

Responsibilities:

• Perform case processing activities including triage, data entry, and report distribution.
• Assess, process, and enter data for all AE case types to meet compliance requirements.
• Perform triage on all case types to determine prioritization as needed.
• Identify adverse events, seriousness, and listedness/labeledness for case assessment; review additional incoming information to determine reportability.
• Perform coding reviews using MedDRA, WHO-DRUG, and Company Product dictionaries.
• Create narrative text as required for medical orientation.
• Determine follow-up requirements and request additional information as appropriate.
• Perform CRO case QC activities and reconciliation as required.
• Work on highest priority or assigned cases using Workflow Management System or as directed.
• Participate in inspections and audits, including interviews and provision of requested data.
• Meet KPIs/KQIs as designated by the company and in compliance with guidelines and policies.
• Assist in writing late ICSR related deviations and CAPAs, upon request.
• Perform additional tasks as assigned, work independently, assess matters, propose resolutions, and appropriately escalate internally.
• Prepare monthly QC metrics and distribute among the team.
• Actively participate in inspection readiness work and respond to FDA queries.
• Perform vendor management activities like coordinating with vendors on ICSR QC activities and voice call QC activities as needed.