What are the responsibilities and job description for the Drug Safety Operations Associate position at cGxPServe?
Job Description
Job Description
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 (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.
- Support ICSR submissions and transmissions as needed.
- 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.
- Meet KPIs / KQIs as designated by Purdue and in compliance with company guidelines and policies.
- 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 Purdue organization.
Requirements :
Necessary Knowledge, Skills, and Abilities :
