Signal Management SOP
Signal detection and assessment.
4 200 Skr
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Purpose:
Defines the process for identification, evaluation, prioritisation, and documentation of safety signals to support ongoing pharmacovigilance activities and benefit–risk monitoring.
Regulatory Alignment:
Aligned with EU pharmacovigilance requirements, including EU GVP Module IX (Signal Management), and relevant EU GMP expectations for quality system interfaces with safety oversight.
Included Files:
• SOP – Signal Management
• Signal tracking and assessment log
• Roles, responsibilities, and escalation overview
Format:
Microsoft Word (fully editable)
Intended Users:
Marketing authorisation holders, pharmacovigilance personnel, quality assurance teams, and regulatory functions responsible for safety signal management activities.