Drug Safety Associate

Perform case processing activities (triage, data entry, report distribution) as required. Assess, process, and data enter all AE case types to meet compliance requirements. Perform triage on all case types to determine prioritization (if requested by Company) Identify adverse events, seriousness, and listedness/labeledness for case assessment; review additional incoming information to determine reportability. Perform all appropriate coding reviews using MedDRA, WHO-DRUG, and Company Product dictionaries. Own case narrative - create narrative text as required for medical orientation. Determine follow-up requirements and request follow-up as appropriate (e-mail, phone call, letter, etc.) to request additional information. Perform CRO case QC activities, reconciliation as required. Work on highest priority or assigned cases using Workflow Management System, or as directed. Participate in inspections and audits as identified, including interviews and provision of requested data. Meet KPIs/KQIs as designated by Company and in compliance with company 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 within company organization. Prepare monthly QC metrics and distribute among the team. Active Participation 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.