What is a Local Safety Officer?
A Local Safety Officer (LSO) is an individual who supports pharmacovigilance activities within a particular country, region or affiliate and acts as a local point of contact for safety-related matters.
Purpose of the Role
Many organisations operate pharmacovigilance systems across multiple countries. Local Safety Officers help ensure that local regulatory requirements, reporting obligations and safety activities are appropriately managed.
Typical Responsibilities
- Local adverse event management
- Regulatory authority interactions
- Local literature activities
- Training support
- Inspection support
- Local compliance monitoring
- Escalation of safety concerns
Relationship with the QPPV
Local Safety Officers do not replace the QPPV. Instead, they support the broader pharmacovigilance system by providing local expertise and operational oversight.
The QPPV remains responsible for overall pharmacovigilance system oversight.
Why the Role Matters
Local regulatory requirements may differ between countries. LSOs help ensure that local obligations are understood and appropriately integrated into global pharmacovigilance processes.
Inspection Considerations
Inspectors may review local pharmacovigilance arrangements and evaluate how local safety activities are governed and integrated within the wider pharmacovigilance system.
Last reviewed: June 2026