Beyond the Checklist: The Power of Soft Skills in Pharmacovigilance Auditing
In the world of Pharmacovigilance, we often fixate on the technical: regulatory requirements, SOPs, and data integrity. While technical expertise is non-negotiable, it is only half the battle. To truly drive improvement and ensure patient safety, an auditor must master the human element. Soft skills are not just “nice to have”; they are essential competencies […]
In the world of Pharmacovigilance, identifying a risk is only half the battle. The true test of a safety system is its ability to manage that risk in the real world. As defined by the EMA GVP Module XVI, risk minimisation measures (RMMs) are interventions intended to prevent or reduce the occurrence of adverse reactions […]
The story of modern drug safety legislation begins with a sweet taste and a devastating consequence. The Sulfanilamide Disaster of 1937 stands as a grim monument to the catastrophic failure of drug regulation, yet decades later, the same toxic culprit—Diethylene Glycol (DEG)—continues to claim lives around the world. This recurrence raises a chilling question central […]
In the world of pharmacovigilance, few adverse events command as much respect and caution as Drug-Induced Liver Injury (DILI). It is a leading cause of acute liver failure in the Western world and remains the single most frequent safety-related reason for the withdrawal of drugs from the market. Whether you are in clinical development or […]
Aviation is a prime example of an industry where lives are at stake, and it shares striking similarities with pharmacovigilance—the science of monitoring and ensuring drug safety. Both operate in highly regulated, complex environments where human factors and automation play critical roles. Here are key lessons pharmacovigilance can learn from aviation’s extensive experience. 1. Safety […]
The other day someone asked me “What does it take to become a PV Auditor? Can I become one?”. I spontaneously responded that you should know the regulations, processes as well as some experience in the quality management system. Then came the tricky question, “How can I become a good PV Auditor?”. I knew this […]
What do you think is the single most important factor for an inspector or auditor? Believe it or not, it is ‘time’. The auditor is already hard-pressed for time and needs to find as many gaps as possible in the stipulated timeframe allocated for the audit. You cannot afford to take any chance, irrespective of […]
“Some things are inevitable during pharmacovigilance audits and inspections; that doesn’t prevent you from preparing!” In today’s world of information technology (IT) advancement, everyone is talking about artificial intelligence, robotics, automation, and machine learning. It is rather unlikely that things would go wrong during an audit or inspection, more so specifically due to a trivial […]
In the complex world of Pharmacovigilance, maintaining compliance isn’t just about monitoring safety data—it’s about monitoring the monitors. Since becoming a mandatory requirement in 2012 (following 2010 EU legislation), the Pharmacovigilance Audit Universe has become the backbone of quality assurance in drug safety. But what exactly constitutes this “universe,” and how do you effectively manage […]
The pharmacovigilance audit universe is not limited to the distributors, business partners, affiliates,and vendors / service providers. One also needs to consider pharmacovigilance processes as well as processes of cross-functional departments which may have a direct or indirect impact on patient safety compliance. These processes are not limited to: Information Technology (including Safety database) Of […]