Pharmacovigilance (PV) plays a central role in protecting patient safety and ensuring regulatory compliance throughout a product’s lifecycle. For every Marketing Authorisation Holder (MAH) in the European Union and the United Kingdom, appointing a Qualified Person for Pharmacovigilance (QPPV) is not just a regulatory requirement but a strategic necessity.

Lambda Therapeutic Research provides QPPV services across the EU and UK, offering companies a reliable framework to meet regulatory expectations and maintain inspection readiness at all times.

Lambda’s QPPV Network: Regional Expertise with Global Oversight

Lambda’s QPPV operations are structured to provide seamless pharmacovigilance coverage across Europe. The team consists of six experienced UK and EU QPPVs, including two deputy QPPVs led by Head of QPPVs/head of EU UK Operations.

This distribution ensures 24/7 accessibility, immediate response to authority requests, and effective coordination with MAHs for ongoing PV compliance. Lambda’s infrastructure allows for uninterrupted monitoring and risk-based oversight across multiple markets.

Scope of Coverage

Lambda’s QPPV team supports an extensive range of Marketing authorisations and product categories, reinforcing its ability to handle diverse regulatory portfolios.

Therapeutic areas: Radiopharmaceuticals, diagnostics, generics, vaccines, biosimilars

This broad exposure enables Lambda to manage the complex regulatory landscapes of multiple therapeutic categories while maintaining uniform compliance standards.

Core Responsibilities of Lambda’s QPPVs

Lambda’s QPPVs perform their duties in alignment with the Human Medicines Regulations (HMR) 2012, as amended, and EMA Good Pharmacovigilance Practice (GVP) Modules. Their key responsibilities include:

• Establishing and maintaining the pharmacovigilance system for each MAH
• Serving as the 24/7 point of contact for the EMA, MHRA, and MAHs
• Overseeing the PV quality system, including SOPs, contractual arrangements, audits, and training compliance
• Maintaining and ensuring accuracy of the Pharmacovigilance System Master File (PSMF)
• Supporting timely and accurate reporting of adverse events, aggregate reports, and signal detection outcomes
• Promoting continuous compliance with legal and regulatory obligations

Each QPPV has the authority and responsibility to influence the quality system, ensuring the pharmacovigilance process remains compliant, traceable, and inspection-ready.

Oversight and Governance Framework

Lambda’s structured transformation enabled a global pharmaceutical client to improve oversight, reinforce compliance, and establish scalable, cost-effective pharmacovigilance operations. Lambda has developed a structured oversight mechanism that enables ongoing supervision of pharmacovigilance activities conducted by MAHs.

Key components of this framework include:

• Monthly PV oversight meetings covering compliance data, periodic reporting, signal activities, and training metrics
• Risk-based escalation allowing early identification and resolution of Identified gaps
• Comprehensive compliance tracking of RMPs, CAPAs, SDEAs, and variation submissions
• Training and audit oversight ensuring all PV personnel remain qualified and compliant
• Regular PSMF updates to reflect the latest system changes and performance indicators

This system ensures that Lambda’s QPPVs maintain both a strategic and operational view of all PV activities, providing clients with transparency and confidence in their compliance posture.

Why Partner with Lambda for QPPV Services

Choosing the right QPPV partner is crucial for achieving both regulatory assurance and operational efficiency. Lambda stands out through its:

• Integrated EU and UK coverage supported by locally based QPPVs
• Proven compliance record across multiple MAHs and therapeutic categories
• Robust communication and reporting framework with competent authorities
• Inspection-ready systems aligned with EMA and MHRA requirements
• Client-specific approach, ensuring adaptable oversight based on risk level and portfolio complexity

By combining regional expertise with global best practices, Lambda offers a complete pharmacovigilance governance solution that supports both innovators and generics manufacturers.

In an increasingly complex regulatory environment, maintaining a strong pharmacovigilance system requires experience, structure, and responsiveness. Lambda Therapeutic Research delivers all three through its dedicated QPPV team serving the EU and UK regions.

With qualified experts, established oversight processes, and a continuous commitment to patient safety, Lambda ensures that every MAH under its QPPV services meets the highest standards of pharmacovigilance compliance.

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Let’s discuss your Pharmacovigilance Needs

Lambda Therapeutic Research provides comprehensive drug safety & pharmacovigilance services, encompassing all clinical and post-marketing phases. Our well-established PV framework ensures thorough safety monitoring and regulatory compliance for both clinical and commercial products, offering end-to-end support across the entire life cycle of medicinal products.

Considering outsourcing pharmacovigilance activities? With evolving regulatory expectations and growing case volumes, having the right partner matters. Lambda’s experienced pharmacovigilance team supports global pharma and biotech companies with solutions that are compliant, scalable, and aligned with regulatory standards.

Connect with us to discuss how we can support your safety operations with the right strategy and infrastructure in place.