Build, expand or transform a pharmacovigilance capability.
HAROM brings together the operating model, quality framework, trained roles and controlled technology required to build or expand a dependable pharmacovigilance capability — from requirement to inspection-ready operations.
From requirement to PV readiness.
PV readiness model
Governance · QMS · Trained roles · Controlled technology
Select the model that fits your current requirement.
Four establishment models, one framework. Open a model to see the approach, the phases and what you achieve.
A functioning PV system — not just documentation.
Every establishment includes the same six elements, evidenced and inspection-ready from go-live.
Defined governance
Clear ownership, QPPV accountability and escalation paths.
Controlled QMS
Approved procedures, quality records and change control.
Trained roles
Documented competency for every PV role, local and central.
Controlled technology
Configured safety systems with role-based access and audit trail.
Traceable operations
Documented workflows and complete audit history.
Ongoing oversight
Metrics, deviations, CAPA and periodic review.
Next step
Ready to establish your PV system?
Discuss your regulatory scope, portfolio and operating model with HAROM's PV establishment specialists.