This SOP defines how pharmacovigilance activities are outsourced, conducted, documented, and reported to ensure patient safety and regulatory compliance.
It outlines the process for collecting, evaluating, and reporting adverse events in accordance with GxP and EMA/FDA requirements.
The SOP is professionally written, pre-filled (≈ 99 % complete), and ready for implementation within your existing QMS framework.
Includes:
• Adverse event collection and processing
• Roles and responsibilities for PV oversight
• Reporting timelines to competent authorities
• Case documentation and database maintenance
• Audit, CAPA, and training references
This document provides a compliant structure for pharmacovigilance operations, ensuring traceability and readiness for authority inspections.
SOP 9 Pharmacovigilance outsourced
Consulting Support
If you prefer expert guidance, OZQA provide QA Services, such as:
- GxP compliance (GMP and GDP)
- ISO 9001 and ISO 13485 quality systems
- QMS structure and implementation
- SOP development and process documentation
- Deviation, CAPA, Change Control, and OOS processes
- Audit and inspection preparation
- Oversight of outsourced partners
Product Details & Purchase Terms
You will receive:
- Downloadable Word files (.docx)
- ~98% pre-filled templates
- Immediate access after purchase
Important:
- No refunds (digital product)
- Requires customization