Drug Safety Associate

• Serve as the primary ICSR case processor, managing end-to-end intake and data entry in Veeva Vault Safety
• Receive, triage, and process all incoming ICSRs — spontaneous, clinical trial, and literature — in Veeva Vault Safety
• Perform MedDRA and WHODrug coding for adverse events, indications, and suspect/concomitant medications
• Assess case seriousness, expectedness (per current IB/SmPC), and causality against source documents
• Author or draft initial case narratives in accordance with ICH E2B(R3) and company SOPs
• Submit 7-day and 15-day expedited ICSRs to FDA, EMA, and other applicable health authorities within regulatory timelines
• Maintain accurate and complete case records in Veeva Vault Safety; apply quality checks before lock
• Execute follow-up requests to clinical sites, reporters, and CROs for missing or incomplete case information
• Support migration of legacy CSPC safety data (~260 cases across 4 studies) into Vault Safety
• Reconcile cases against Veeva EDC and partner safety databases as required
• Assist in preparation of line listings and case data extracts for DSURs and PBRERs
• Contribute to SOP authoring and maintenance as PV processes are established in-house
• Participate in audit and inspection readiness activities; retrieve case documentation as requested
• Support periodic reconciliation activities with CRO and clinical partners

Drug Safety Associate I

• Support ICSR case processor, managing end-to-end intake and data entry in Veeva Vault Safety.
• Perform MedDRA and WHODrug coding for adverse events, indications, and suspect/concomitant medications.
• Assess case seriousness, expectedness (per current IB/SmPC), and causality against source documents.
• Author or draft initial case narratives in accordance with ICH E2B(R3) and company SOPs.
• Submit 7-day and 15-day expedited ICSRs to FDA, EMA, and other applicable health authorities within regulatory timelines.
• Maintain accurate and complete case records in Veeva Vault Safety; apply quality checks before lock.
• Execute follow-up requests to clinical sites, reporters, and CROs for missing or incomplete case information.
• Support migration of legacy CSPC safety data (~260 cases across 4 studies) into Vault Safety.
• Assist in preparation of line listings and case data extracts for DSURs and PBRERs.
• Contribute to SOP authoring and maintenance as PV processes are established in-house.
• Participate in audit and inspection readiness activities; retrieve case documentation as requested.
• Support periodic reconciliation activities with CRO and clinical partners.

See all jobs on JobTailor

Drug Safety Associate I

Drug Safety Associate I – Contractor