Local QPPVs Services (Local Safety Officer)

Local Qualified Person for Pharmacovigilance (LQPPV)

LQPPV services with DrugCard, combining expert guidance and technology to keep patients safe, maintain product safety, and ensure regulatory compliance worldwide.

Our Local QPPV Services: Scope and Deliverables

End-to-End Pharmacovigilance Oversight

The local qualified person for pharmacovigilance supervises country-level pharmacovigilance activities, aligning local pharmacovigilance systems with regulations and maintaining drug safety and accurate medical information across all operations.

Local Safety Intelligence and Signal Escalation

Relevant safety signals, adverse events, and medical information are reviewed and communicated to regulatory authorities and the EU QPPV in accordance with local regulations and European Union requirements.

24/7 Availability and Regulatory Contact Point Duties

Local persons serve as the single point of contact, supporting urgent requests and inspections 24/7 from patients, regulatory authorities, and the head office.

Support with RMP, PSMF Maintenance, and PV Audits

We maintain annexes of the PSMF, manage Risk Management Plan activities, and prepare for audits. We also handle periodic documentation, including RMPs, PSURs, ACOs, and other required submissions. All documentation is aligned with EU and UK regulations to ensure inspection readiness, product safety, and patient safety.

Benefits of Choosing a SaaS-Enabled Local QPPV Model

DrugCard’s SaaS-enabled LQPPV model delivers:

Qualified local expertise under expert supervision

Centralized oversight for consistent country-level PV and drug safety, providing scalable solutions for pharma companies in regulated markets

Improved visibility of safety activities and adverse events, supporting patient safety

Structured compliance for marketing authorization holders

Expert-controlled operations monitored continuously, supporting your local PV strategy

Adaptive system refined by PV specialists

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How Our Platform Supports Local QPPV Operations

DrugCard integrates LQPPV and local pharmacovigilance services with specialist oversight, centralizing safety data, documentation, and workflows. Artificial intelligence supports automated monitoring and enhances regulatory compliance across local and global environments.

Automated Case Intake and Processing

The system collects updates from all connected health authority websites.

Integrated PSMF and SOP Management

Centralized PSMF, SOP, and additional medical information management ensure traceability and alignment between local qualified persons for pharmacovigilance and global pharmacovigilance systems.

Audit-Ready Documentation

You receive structured updates, alerts, and search-ready content for fast compliance actions.

Workflow: How We Deliver Local QPPV Services

Step 1 – Regulatory Assessment

Review local pharmacovigilance requirements, country-specific regulations, and national legislation to define the scope for a local qualified person responsible.

Step 2 – QPPV Assignment

Assign a LQPPV for pharmacovigilance or local representative to manage compliance.

Step 3 – System Integration

DrugCard connects case intake, PSMF, SOPs, and safety data, integrating with the local pharmacovigilance system and global oversight to ensure streamlined compliance and safety management.

Step 4 – Safety Monitoring

The person responsible for pharmacovigilance tracks adverse events and adverse drug reactions in the local language, where required, ensuring accurate reporting and compliance with regulatory requirements at local and EU levels.

Step 5 – Compliance & Documentation

Inspection-ready records are maintained, ensuring adherence to local and EU regulations and supporting regulatory reviews and audits.

Step 6 – Continuous Optimization

The QPPV works with experts and a graduated plan officer to refine workflows, update procedures, and support maintaining regulatory compliance while ensuring consistent drug safety.

Why Choose Us as Your Partner

We provide local PV expertise supported by expert qualified persons for pharmacovigilance. DrugCard combines EU QPPV services, global experience, and advanced technology to ensure drug safety and act as the local contact person for authorities.

Certified Safety Experts with Global Experience

Our team includes medically qualified professionals with extensive experience in local regulations and country-specific PV requirements.

Proven Technology in Pharmacovigilance Operations

DrugCard platform supports local pharmacovigilance operations, integrating case processing, PSMF, SOP management, and regulatory intelligence for audit-ready compliance.

How Fast Can Services Be Activated?

Local PV services can typically be established within weeks, providing immediate support for compliance and patient safety.

Frequently Asked Questions (FAQ)

How does a LQPPV interact with the EU QPPV?

The LQPPV operates in coordination with the EU QPPV, ensuring country-level pharmacovigilance activities are aligned with global safety governance, escalation pathways, and oversight expectations.

What happens during a regulatory inspection at the country level?

The LQPPV acts as the single point of contact during inspections, supports communication with national competent authorities, and ensures immediate access to required pharmacovigilance documentation.

Can LQPPV services be scaled across multiple countries?

Yes. The SaaS-enabled model enables centralized oversight while preserving local execution, supporting global consistency across markets with differing regulatory requirements. This scalability is built on proven strategies for managing pharmacovigilance activities across multiple countries and regulatory jurisdictions.

How does DrugCard support quality management in pharmacovigilance?

DrugCard supports quality through controlled workflows, documented procedures, and real-time reporting aligned with established regulatory standards. Expert oversight ensures consistent quality management across pharmacovigilance operations, even in diverse regulatory environments.

Who retains accountability for pharmacovigilance compliance?

Accountability remains clearly defined between the marketing authorization holder, the EU QPPV, and the QPPV. Clearly documented roles, responsibilities, and oversight models support maintaining compliance with both local requirements and international regulations.

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