Pharmacovigilance specialist with a PhD on hormonal regulation in an animal model and a recent MSc in Clinical Epidemiology. Manages pharmacovigilance systems for different clients and acts as QPPV for a number of them, creates safety data exchange agreements, ensures quality control and reporting compliance. Author of numerous scientific publications and safety reports on a variety of drugs and indications. Interested in the training of personnel, compliance monitoring, regulatory drug safety and quality assurance from clinical development for investigational to post-authorisation vigilance for (non-)marketed products. Proactive teamplayer with a high problem-solving capacity and good intersocial skills, cross-departmental expertise towards regulatory and clinical and non-clinical services for our clients. Management Team member of DADA, mother of two boys (happily married to their dad), alpha-lady to our Sheltie and broadly interested in science and nature. Specialties: Provide tailor made pharmacovigilance support, including QPPV provision and responsibility for the clients pharmacovigilance systems and cross-link to medical information. Create safety data exchange agreements on behalf of our clients, database management of patient reports on adverse events related to medicinal product use, give training on basic and advanced pharmacovigilance, write periodic reports on the risk-benefit balance of pharmaceutical products by evaluating literature, case reports and all other relevant sources. Monitor the department for quality and compliance.In case you need any support with the above, do not hesitate to reach out!