I am a pharmacovigilance professional focused on patient safety, regulatory compliance, and the operational side of keeping medicinal products safe in real-world use. PV is what I do day-to-day, and what I care about most.
I hold a degree in Pharmacy and am finishing a Master's in Medical and Pharmaceutical Biotechnology. Over the past several years I have built end-to-end PV experience across consulting and in-house roles, including ICSR processing and triage, signal detection, literature monitoring, MedDRA coding, and xEVMPD submissions. I rebuilt a complete PV system from scratch at one company, drafted regulatory documents such as RMP, SmPC, and Clinical Overview, authored SOPs and PSMF documentation, and participated in GVP and GDP inspections. Alongside this, I am completing a research placement in computational drug design.
I think there is a lot of room to make pharmacovigilance smarter and more automated without losing the rigor that drug safety demands. That is something I am actively working on, not just thinking about. I am always looking to learn something new and pick up skills that move the work forward.