What is a Safety Signal?
A safety signal is information that suggests a new potential causal association, or a new aspect of a known association, between a medicinal product and an adverse event that warrants further investigation.
Why Safety Signals Matter
The primary objective of pharmacovigilance is the continuous monitoring of medicinal product safety. Safety signals provide an early warning mechanism that helps identify emerging risks affecting patients.
Not every signal represents a confirmed safety issue. Signals are hypotheses that require evaluation before regulatory or clinical conclusions can be reached.
Sources of Safety Signals
- Spontaneous adverse event reports
- Clinical trials
- Medical literature
- Patient support programmes
- Scientific publications
- Regulatory authority communications
- Post-authorisation studies
The Signal Management Process
- Detection
- Validation
- Prioritisation
- Assessment
- Recommendation
- Communication
Role of the QPPV
The QPPV is expected to maintain awareness of significant signal management activities and ensure appropriate governance arrangements are in place.
Although signal detection activities may be delegated, the QPPV should understand how important safety issues are escalated, reviewed and managed.
Potential Outcomes
- No further action required
- Additional monitoring
- Label updates
- Risk minimisation measures
- Further studies
- Regulatory action
Inspection Perspective
Inspectors frequently review signal management processes, governance arrangements and documentation to assess whether emerging safety concerns are appropriately identified and managed.
Last reviewed: June 2026