How I became a PV auditor: A winding path, the courage to say “Yes” and a team that supports

Almost three years ago, I started my professional journey in the Biocodex Phame team. I joined gradually—initially supporting the main specialist. My responsibilities at the time were quite technical: QC of translations, artwork checks, and reviewing promotional materials. It was a great start—I had the chance to learn, observe, and understand how the pharmaceutical world works from the inside.

Later, I had the opportunity to join the quality team, where I began registering product quality complaints. This was a turning point—I started to dive deeper into quality processes and understand their importance and impact on patient safety. Eventually, I became an LDSO deputy. That’s when my path in PV truly began—I started monitoring digital media pages, and local literature screening became my responsibility.

So how did I go from these seemingly simple tasks to PV audits? One day, my amazing supervisor asked me: “Ugnė, would you be interested in becoming an auditor in the future?” My first instinct is always to say YES. It’s a chance to learn something new, to grow. So, I said, “Yes, I’d love to. It sounds interesting.”

But as I started to explore how audits work, stress kicked in. So many responsibilities, so much multitasking. I began to question whether I had the qualities needed to be an auditor—would I be able to handle it? Would I enjoy it? But I knew that in our team, no one is thrown into work without proper training and preparation. And I also knew that if it didn’t feel right, I could always say this path wasn’t for me.

In our team, everyone is a professional, an expert in their field. Nothing happens without training, support, and plenty of tricks and tips. So, I began my journey into audit training. My colleagues provided training, I observed internal audits and participated in several external ones.

Then everything paused – I became the main person responsible for Lithuania, not only for my daily tasks but also taking over all responsibilities from a colleague: RA, LDSO deputy, marketing material checks, and quality.

The path to becoming an auditor is never straight. Once I settled into my new responsibilities, I returned to training. I believe this time also contributed to my growth—especially in the auditor’s mindset. I learned to spot details, recognize what works and what doesn’t, and where mistakes tend to happen.

The second phase of training was more intense. I had the basics – now I just needed a push. Encouraged by colleagues who saw my potential, I participated in an external audit where I led one audit section. And it went well! I didn’t stumble over my words, I remembered how to speak, and my voice didn’t even shake. That was my first confidence boost. The second came when a colleague who joined the audit praised my performance.

In the next audit, I was ready and eager to lead not just one, but several sections. And I believe that in the near future, I’ll become a fully-fledged auditor.

This journey, lasting over a year, was winding. It came with stress and additional responsibilities. But the most important part was having a great team that pushes you forward when you’re unsure. And learning to push yourself—to say “yes,” even when you’re doubting. Maybe it’s not your path—but you’ll never know unless you try.

Author: Ugnė Ruminė, Regulatory Affairs Specialist