Assignment Description: JOB SUMMARY + Position performs adverse event processing responsibilities supporting the Case Management function within Drug Safety Operations. Primary Responsibilities + 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 + Identify adverse events, seriousness, and listedness / labeledness for case assessment; review additional incoming information to determine reportability + Select the appropriate as reported causality and company causality + 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. + Support ICSR submissions and transmissions as needed + 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 within organization Education and Experience 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 + FDA pharmacovigilance inspection experience preferred Necessary Knowledge, Skills, and Abilities + Resource and workflow management (monitoring and assigning tasks) + MedDRA coding + Considers present and future impacts when making recommendations + Strong negotiation and problem-solving skills + Analytical skills and attention to detail + Accountability – takes ownership of deliverables + Possible relevant titles: Seasoned PV lead or QC Associate on a CRO team