Reliable vendor management
VigiDirect
On VigiDdirect, you will find comprehensive resources on how to set up, monitor, and independently verify vendors within your (pharmaco)vigilance system. We provide structured approaches to help you navigate vendor selection, from defining qualification criteria and conducting due diligence to ensuring that all regulatory and contractual requirements are met.
Beyond the initial setup, we also offer insights into ongoing vendor management, including performance monitoring, KPI tracking, audits, and compliance checks to ensure that vendors consistently meet regulatory expectations and business needs. VigiDirect provides best practices for identifying, assessing, and mitigating risks, helping you maintain strong, transparent vendor relationships that fully comply with pharmacovigilance requirements and industry standards.
For those who want an extra layer of assurance, we also provide independent vendor verifications and audits. This ensures that your outsourced pharmacovigilance activities meet both internal quality standards and EU regulatory requirements.
Establishing and Managing Vendors in a (Pharmaco)vigilance System
Effective vendor management is a critical component of a compliant pharmacovigilance and medical device vigilance system, ensuring that outsourced activities meet regulatory and quality requirements. When selecting a vendor for pharmacovigilance or medical device vigilance services—whether for case processing, signal detection, literature monitoring, QPPV or Person Responsible for Regulatory Compliance (PRRC) functions, automated safety systems, or post-market surveillance (PMS) activities—it is essential to conduct a thorough qualification process. This includes assessing the vendor’s experience, compliance history, capabilities, and understanding of EU-GVP requirements for pharmacovigilance, as well as MDR and IVDR obligations for medical devices.
A well-defined vendor agreement—such as a Safety Data Exchange Agreement (SDEA), Pharmacovigilance Agreement (PVA), or Vigilance Agreement for medical devices— has to outline roles, responsibilities, timelines, and reporting obligations to ensure seamless collaboration and regulatory adherence. For medical devices, this includes ensuring that vendors comply with post-market surveillance (PMS) and vigilance reporting requirements under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). Additionally, vendors providing field safety corrective action (FSCA) management, trend analysis, and incident reporting has to demonstrate compliance with ISO 13485 and ISO 14971 to ensure risk-based decision-making and data integrity. Ongoing audits, performance monitoring, and compliance reviews are necessary to ensure that vendors consistently meet contractual and regulatory obligations, supporting both patient safety and regulatory compliance.
Ongoing Vendor Oversight and Performance Management
Once a vendor is onboarded, continuous monitoring is necessary to maintain compliance and operational efficiency. This includes regular audits, performance reviews, KPI tracking, and quality assessments to ensure the vendor delivers as expected. It is crucial to establish clear communication channels and conduct periodic meetings to address any issues proactively. Vendors should be required to provide detailed reports and documentation that demonstrate adherence to pharmacovigilance processes and regulatory timelines. Any deviations or quality concerns has to be handled promptly through a structured CAPA (Corrective and Preventive Actions) process to mitigate potential risks.
Risk Management in Vendor Oversight
Vendor-related risks in (pharmaco)vigilance can range from non-compliance with reporting timelines to data security breaches and process failures. To minimize these risks, companies should implement a risk-based approach in vendor selection and management. This involves conducting risk assessments, identifying critical areas of vendor involvement, and applying appropriate controls to mitigate risks. Key measures include contractual obligations, data protection policies, redundancy planning, and contingency strategies to ensure uninterrupted pharmacovigilance operations. By proactively managing vendor relationships and addressing risks, companies can maintain a robust, compliant, and efficient (pharmaco)vigilance system while leveraging external expertise effectively.