Drug Safety Associate

Axelon Services CorporationStamford, CT

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Job Description

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.

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FAQs About Drug Safety Associate Jobs at Axelon Services Corporation

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This job at Axelon Services Corporation is located in Stamford, CT, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.

What pay range can candidates expect for this role at Axelon Services Corporation?

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