The Role of a PV Auditor: Lessons learned and confidence gained through experience

Almost a year ago, I shared my thoughts on becoming an auditor – the challenges, the positive sides, and how my training went. Now, nearly a year later, I thought it was time to share how everything is going.

At the beginning, the plan was for me to become a lead auditor at the start of the year, with a more experienced colleague joining me and, if needed, taking the lead in one section or another. However, life happened, and our already small auditor team in Phame became even smaller. We simply didn’t have the luxury of following that plan. So, once again, I had to step outside my comfort zone and become a lead auditor on my own from day one.

So, what happen?

Before my first audit, I was stressed. I knew all the steps, and I knew I was as prepared as I could possibly be (a huge thanks to all my trainers for that), but the stress didn’t go away. I mentally prepared myself, imagined all the worst-case scenarios… and none of them happened.

Instead, I had the opportunity to meet people who were an absolute pleasure to work with. We had great discussions throughout the audit, and the entire process went as smoothly as I could have hoped. Afterwards, I was genuinely happy with how everything had gone.

Then, of course, the darker thoughts appeared. Maybe it was simply because the company and its people followed everything by the book? Maybe I had missed something that I should have found?

After conducting my second audit on my own, I realized that I am capable of finding what needs to be found. Whether findings exist or not depends on how well the company follows its pharmacovigilance responsibilities.

Another very positive side of audits is the opportunity to meet new people with every audit. I get to see different company cultures, different ways of working, and sometimes even different interpretations of internal and external requirements. It reminds me how different we all are, and I think that’s one of the most interesting parts of this job.

The second major part of auditing is writing the audit report in a way that allows someone who wasn’t there to clearly understand what happened, why the findings are important, and what was discussed during the audit. While I now feel much more comfortable conducting audits, report writing is still not my strongest skill. But at the same time, I know exactly where I need to improve.

Practice really does make us better, and I can see that in myself. After every audit, I feel just a little more confident and a little more comfortable with PV audits.

Once again, I would like to thank my colleagues who believed in me from the very beginning and trained me so well. I’m also grateful to our HQ PV colleagues for developing an AI chatbot tool, which has been a great support in report writing and formulation.

I still have one more role that continues to challenge me: being an internal auditor. It still stresses me almost as much as it did at the beginning, but I guess that’s life. Without uncomfortable situations, we simply don’t grow. Growth rarely happens inside our comfort zone, and I guess becoming an auditor has reminded me of that more than once.

Author: Ugnė Ruminė, Regulatory Affairs Specialist