audit
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 […]
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 […]
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 […]
It is at the discretion of an inspector to request documents before, during, and after an inspection. A document request after an inspection may call for a surprise even if the closing meeting was uneventful. On-site Vs Remote For obvious reasons, remote inspections are expected to have more document requests before the inspection as compared […]
In the current era, the pharmaceutical industry is witnessing a surge in Mergers and Acquisitions (M&A). As a result, the concept of due diligence has gained significant importance. While there are similarities between audits and due diligence—specifically regarding the review of systems—their fundamental purposes are distinct. Understanding these differences is crucial for Pharmacovigilance professionals navigating […]
A pharmaceutical company is any commercial entity that may be associated with research, manufacturing, commercialization or distribution of medicinal products. This entity may or may not own the product license, and this factor may decide if this entity will or will not fall under the purview of pharmacovigilance regulations. That doesn’t prevent the company personnel […]
Working in the pharmacovigilance department can be a ‘happening one’ or even a roller-coaster ride. This is irrespective of whether you work for a pharmaceutical company, service provider, monitoring centre, or regulatory agency. Dealing with the rigmarole is going to be a rewarding experience and a satisfying one as you ultimately contribute to the welfare […]
The Pharmacovigilance function is required to have a robust Quality Management System (QMS) and for this, one needs to have efficient standard operating procedures or SOPs. Apart from the SOPs, one can consider other documents, such as working practices (work instructions) or guidelines/guidance documents, as recommended in the QMS of the organization. The list of […]
It was July 2012 when the European Medicines Agency made it mandatory for all the marketing authorization holders (MAH) to maintain the Pharmacovigilance System Master File (PSMF) as per the GVP Module II. Until then, the document was a concise one and called as the detailed description of Pharmacovigilance system (DDPS). After the PSMF came […]