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Global Network of Local Safety Officers

You stay focused on your products and patients. We take care of the local PV complexity.

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Global Reach. Local Expertise. One PV Network.

One partner to manage your local pharmacovigilance obligations across markets, with local expertise where it matters and central oversight to keep everything connected.

Navigating local PV requirements can be complex. Bpharma simplifies this through an established network of Local Safety Officers (LSO) and Local Persons Responsible for Pharmacovigilance (LPPV), coordinated via a centralised governance model.

Country-specific feasibility and service availability are confirmed for each project. Regulatory obligations and authority decisions remain with the applicable responsible parties.

Our local experts act as an extension of your global pharmacovigilance organisation, translating country-specific requirements into practical, compliant action.

In detail

More than local representation

End-to-end local pharmacovigilance support.

  1. 01

    Local Safety Expertise
    Qualified local PV professionals with in-depth knowledge of national regulation and authority expectations.

  2. 02

    Central Coordination
    One governance structure, harmonised processes and clear communication across the countries in scope.

  3. 03

    National / Local QPPV Coverage
    Responsible persons and deputies to support continuous local coverage and regulatory compliance, depending on the country and the agreed scope.

  4. 04

    Scalable Global Coverage
    Flexible support as you enter new markets, expand your portfolio or acquire new products.

Key points

QPPV services – LPPV and LSO network

What the Qualified Person for Pharmacovigilance (QPPV) role covers, depending on the country and the agreed scope:

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  • Serving as the 24/7 contact point for EU Competent Authorities and the European Medicines Agency (EMA) for pharmacovigilance and benefit-risk matters
  • Local processing of Individual Case Safety Reports (ICSRs), including reporting to the local Competent Authority, where applicable
  • Appropriate documentation and oversight of suspected adverse reactions
  • Delivery of pharmacovigilance training to local Marketing Authorisation Holder (MAH) personnel
  • Keeping the Pharmacovigilance System Master File (PSMF) accurate and up to date
  • Continuous monitoring of product safety profiles and emerging safety concerns
  • Oversight of compliance of pharmacovigilance activities and submissions with Good Pharmacovigilance Practice (GVP) and applicable regulatory requirements
  • Acting as the main PV contact during audits and inspections
  • Oversight of the preparation and submission of Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) to relevant authorities

Scope

We take care of the local PV complexity

Local PV oversight

  • National / Local QPPV & Deputy
  • Local Authority Contact
  • Local PV Regulatory Intelligence
  • Local PV System Oversight

Safety operations

  • Local ICSR Intake & Follow-up
  • Local Literature Screening
  • Safety Information Exchange
  • Reconciliation Support

Compliance & risk management

  • Local Regulatory Compliance
  • Additional Risk Minimisation Measures (aRMM) Implementation & Tracking
  • Local Safety Requirements
  • Regulatory Change Implementation

Inspection readiness

  • Local Audit & Inspection Support
  • Documentation Readiness
  • Corrective and Preventive Action (CAPA) & Follow-up Support
  • Continuous Compliance Oversight
  • IntegratedConnected with your global PV system
  • CompliantAligned with local PV requirements
  • ControlledContinuous QPPV oversight
  • ScalableEasily adapted as your portfolio grows

Be healthy Be safe Be well