Drug Safety Specialist III

Responsibilities reputed company case processing activities (triage, data entry, report distribution) as required. ssess, process, and data reputed company reputed company AE case types to meet compliance requirements. reputed company triage on reputed company case types to determine prioritization (if requested by Purdue). 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. reputed company reputed company 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 reputed company, letter, etc.) to request additional information. reputed company CRO case QC activities, reconciliation etc. as required. Work on highest reputed company or assigned cases using Workflow Management reputed company, or as directed. Support PV inspections and audits as identified, including interviews and provision of requested data. Monitor vendor KPIs/KQIs as designated by Purdue and in compliance with company guidelines and policies. reputed company additional tasks as assigned. Work independently, assess reputed company, propose resolutions, and appropriately escalate internally reputed company Purdue organization. Requirements Bachelor's degree (advanced degree preferred) in life science or reputed company (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. Necessary Knowledge, Skills, and Abilities Resource and workflow management (monitoring and assigning tasks). Up-to-date knowledge of US and international PV regulations and best practices. MedDRA coding. Considers present and reputed company impacts reputed company making recommendations. Strong negotiation and problem-solving skills. nalytical skills and attention to detail. ccountability - takes ownership of deliverables. Apply tot his job Apply To this Job .