Drug Safety Assistant II

Job Title: Drug Safety Assistant llEnsure all your application information is up to date and in order before applying for this opportunity. Location: Stamford, CT Schedule: M-F 9 AM- 5 PM Type: Contract Responsibilities: Position performs adverse event processing and submission responsibilities supporting the Case Management function within Drug Safety Operations. Perform case processing activities (triage, data entry, report distribution) as require. Assess, process, and data enter all AE case types to meet compliance requirement. Identify adverse events, seriousness, and listedness / labeledness for case assessment; review additional incoming information to determine reportability Perform all appropriate coding 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 etc 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. 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 Requirements: Bachelor's degree (advanced degree preferred) in life science or healthcare (e.g. nursing, pharmacy) Minimum 5 years of experience in a pharmaceutical/biopharmaceutical company Minimum 3 years in Drug Safety Operations role; Experience overseeing CRO teams of case processors preferred US FDA pharmacovigilance inspection experience preferred Benefits System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan. Ref: #558-Scientific

Created: 2025-03-06