At Pharming Technologies NV, I processed and validated safety reports for investigational and marketed products, including coding and causality assessment. I also supported preparation and review of periodic safety reports.
I used the PV deviation tracker to document non-conformances and reporting delays, and assisted quality investigations into submission bottlenecks. I also authored and revised pharmacovigilance SOPs and work instructions.
At Janssen Biologics BV, I managed clinical trial data and document submissions to global registries, including ClinicalTrials.gov and EudraCT/CTIS. I tracked submission milestones and worked with clinical trial and regulatory teams to address data discrepancies.
Earlier, at Elanco Innovation and Alliance Centre, Syneos Health, and IQVIA, I processed and reviewed safety cases, assessed adverse event data, and contributed to safety narratives and literature surveillance. I hold a Doctor of Pharmacy (PharmD) and a Pharmacovigilance Quality Management Systems (PV QMS) certification from the Drug Information Association.
