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Pharmacovigilance

Building a Global PV Operating Model Without Losing Control

February 3, 20268 min read

Global coverage adds complexity quickly: jurisdiction variation, timezone handoffs, partner interfaces, and documentation fragmentation.

The control point should be a single operating model with regional adaptations, not region-specific silos.

Practical architecture

  • Define a global core workflow with mandatory quality gates.
  • Keep market-specific addenda modular.
  • Standardize escalation and handoff language.
  • Maintain one source of truth for SOP revisions.

Governance rule

Scale only what can be monitored. If a process cannot be measured and reviewed, it should not be multiplied across geographies.

Outcome

Teams gain speed without losing traceability, and regulatory responses stay coherent across authorities.

Related resources

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