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 wasn’t going to be easy, but I still made an attempt and hence thought of sharing it here.

1. Sacrifice – Yes, one might need to give up the current role to get into full-time PV auditing. At least for me, it was not easy after heading global pharmacovigilance in various pharma companies for 10 long years, to take this decision. It is an interesting journey from managing large teams to becoming an SME. One day you are making decisions for your team, and the other day you are deciding on what observations to give to the auditee. The transition is not easy unless one is motivated to do it.
2. Subject matter expertise – Yes, one needs to be adept in identifying gaps quickly. Having good knowledge of ICSRs, aggregate safety, risk and signal management, safety agreements, labeling, and most importantly the PSMF is important. Although the QPPV office and 100+ countries were under my purview, I always prioritized technical expertise over managerial, and that really helped. I also made sure to train my team on whatever new I had learnt.
3. Preparedness – The work is half done when you have thoroughly gone through the pre-audit documents. It is a great feeling when you have identified even a small flaw before the audit.
4. Sharpening the Saw – Keeping abreast of emerging pharmacovigilance regulations is important and gives you an edge over others. The auditees also feel comfortable that their systems would eventually become robust, irrespective of the audit outcome.
5. Soft-skills – Good negotiation skills are important especially when you have a confident and seasoned auditee who would be ready with a justification. However, one should not forget that the regulatory requirements would always prevail.

Feeling the pressure as an auditor is common, especially in the early stages of your career. The journey from a novice to a seasoned auditor is filled with learning and growth. While the fear of not uncovering issues during audits may linger, remember that your skills will sharpen over time.

As you gain experience, your confidence levels will naturally rise, leading to more successful audits. It’s normal to worry about missing something during your next audit, but trust in your abilities as a competent auditor. Your expertise and diligence will guide you to identify areas that need attention. Keep honing your skills, and you’ll consistently deliver valuable insights during audits.