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 System, 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