Drug Safety Specialist III
Responsibilities:
• Perform case processing activities (triage, data entry, report distribution) as required.
• ssess, process, and data enter all AE case types to meet compliance requirements.
• Perform triage on all 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.
• 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.
• 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.
• Perform additional tasks as assigned. Work independently, assess matters, propose resolutions, and appropriately escalate internally within Purdue organization.
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.
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 future impacts when making recommendations.
• Strong negotiation and problem-solving skills.
• nalytical skills and attention to detail.
• ccountability - takes ownership of deliverables.
• Perform case processing activities (triage, data entry, report distribution) as required.
• ssess, process, and data enter all AE case types to meet compliance requirements.
• Perform triage on all 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.
• 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.
• 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.
• Perform additional tasks as assigned. Work independently, assess matters, propose resolutions, and appropriately escalate internally within Purdue organization.
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.
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 future impacts when making recommendations.
• Strong negotiation and problem-solving skills.
• nalytical skills and attention to detail.
• ccountability - takes ownership of deliverables.