Stage 9 · Toolkit 9.3
Signal Management
Detect, validate, prioritise, assess, escalate, document, and close safety signals.
What it helps control
Operational support
Helps teams establish the procedures, working records, trackers, and evidence needed for Signal Management.
How it helps your team
Connect day-to-day safety operations with visible ownership, evidence, and inspection readiness.
Designed for
QPPVs, Heads of Pharmacovigilance, Drug Safety, PV Operations, Medical Safety, Quality, and affiliate teams.
Included files
Know exactly what the toolkit contains
The file names below show what is included. File contents become available only after purchase.
Word documents
- Signal Management SOP
- Signal Detection Plan
- Signal Validation Template
- Signal Assessment Report
- Signal Escalation Template
- Signal Decision Memo
Excel workbooks
- Signal Tracking Log
- Signal Review Meeting Tracker
- Emerging Risk Tracker
- Signal Evidence Matrix
Related toolkits
Continue within stage 9
ICSR Case Management
Manage adverse event case intake, processing, QC, medical review, reporting, follow-up, and closure.
9.2Literature Surveillance & Review
Manage literature search, screening, medical review, reportability, and evidence of surveillance.
9.4Risk Management / RMP
Manage safety concerns, RMP commitments, risk minimisation, effectiveness, and updates.