mars gebrehiwet

I am a dedicated Pharmacovigilance Scientist currently based in Luxembourg, with extensive experience in safety signal detection, case processing, and risk management for pharmaceutical products. My role at BioNext involves ensuring compliance with global pharmacovigilance regulations, including those set by the FDA, EMA, and WHO. I take pride in training and mentoring both students and professionals, fostering a culture of safety and compliance in the industry.

Previously, I worked as a Drug Safety Associate at the Federal Institute For Drugs and Medical Devices in Germany, where I processed Individual Case Safety Reports and conducted literature surveillance to identify emerging drug safety concerns. My commitment to drug safety extends to my work in Africa, where I led training programs and implemented ADR reporting systems to enhance pharmacovigilance in underprivileged communities.

With a Master’s degree in Pharmacovigilance and Drug Safety, I have developed a strong foundation in regulatory compliance and risk management. My projects have included the implementation of AI-based signal detection models and the creation of regulatory compliance frameworks for drug safety monitoring in GCC countries, demonstrating my ability to innovate and improve pharmacovigilance practices.