Hello! I am a Biologist with a specialization in Biotechnology. I began my professional career in The Netherlands working on nutrition research. After that, I moved to the Biotechnology industry into the challenging world of orphan drugs where I started to build my expertise in Pharmacovigilance (PV) and Quality Assurance (QA).
Since then, I have worked for more than 16 years in the Biotechnology, Pharma and Medical Devices industry in both pharmacovigilance and quality assurance capacities and in both large and medium size companies with varying levels of responsibility. I have extensive international experience working for both US and European companies and possess a good understanding of international and local regulations.
I have been involved in the initial set up of a Pharmacovigilance department, due diligence work, acquisitions, and numerous pharmacovigilance inspections from different European Regulatory Authorities and FDA. My career as an auditor began in 2004 from the work carried out during the preparation of a MHRA Inspection, where I worked closely as a PV expert with the Quality Assurance department. Subsequently I started in the auditing world as a GCP auditor to later also become a GVP auditor. During my time work in the Medical Devices field I received certified training as an ISO 9001 auditor.
The experience gained from these working years, combined with my studies in Coaching and personal leadership, developed and refined the skills needed to successfully and efficiently carry out projects and lead diverse teams. I worked on both the client and the provider side which gave me the required skills to accomplish the program objectives.
I am a dynamic, self-motivated, hard-working person with excellent empathy and communication skills. Quality, objectivity and an eye for detail describe my work.
I look forward to contributing to your next Pharmacovigilance or Quality Assurance project!