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ServiceUpdated on 17 August 2025

Pharmacovigilance Services

Jane Müller

Head Legal, Business Development representative at Luminance Health

Basel, Switzerland

About

The main Pharmacovigilance services areas include:

  1. PV Mandates

    • EU QPPV & UK QPPV

    • EudraVigilance Responsible Person

    • Swiss PV Responsible Person

    • EU local QPPV services

  2. PV Systems

    • PSMF (EU & UK) creation and update

    • PV specific SOPs

    • Gap assessment and inspection readiness

    • Offering operational PV support withing client PV system

  3. PV Compliance

    • GVP & GCP Audits

    • PV Mock inspections

    • PV Agreements

    • PV Regulatory intelligence

  4. PV Operations

    • Signal management

    • RMP and Aggregate reports (PBERE, PSUR & DSUR)

    • XEVMPD activities (AMP/DMP entry and maintenance)

    • Global & local literature search and strategy

Type

  • Consulting
  • Others

Applies to

  • Development stages and support fuctions - Clinical research and development
  • Development stages and support fuctions - Regulatory and compliance

Organisation

Luminance Health

Consultant

Basel, Switzerland

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