quality

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 […]

Many Pharmacovigilance and Quality personnel have approached me in the last few years, requesting a Pharmacovigilance Audit Checklist. I also used to be happy to share the version I had prepared in 2012 for my first audit assignment in the European Union. Some of the requestors reverted, stating that the checklist served the purpose, and […]

The Pharmacovigilance (PHV) department is the heart of drug safety, but its health depends entirely on the arteries and veins that feed it—the allied functions across your organization. When a regulatory agency (like the MHRA, FDA, or the EMA) arrives for an inspection, they aren’t just looking at your PHV team’s SOPs and case processing […]

In the last few years, after having audited numerous service providers/ business or licensing partners/ distributors etc., I realized having developed fascination towards this off-shoot of Pharmacovigilance, that is #PhVQA. Thanks to the GVP modules as well as PSMF pre-requisites, coupled with the requirements for MAH to maintain a 2-5 yearly audit schedule, making it […]

Common questions asked by the Pharmacovigilance Inspector, with regards to Pharmacovigilance vendors