Renata Simon

I am a dedicated pharmacovigilance professional with extensive experience in case processing, data analysis, and quality assurance. My journey in this field began with my academic background in medicine, which laid the foundation for my career. I have honed my skills in case registration, quality checks, and adverse event reporting, ensuring compliance with regulatory guidelines such as ICH, FDA, and EMA.

At Gedeon Richter Romania, I currently serve as a GMP-GVP Coordinator, where I lead efforts in maintaining the pharmacovigilance quality assurance system and managing audits. My role involves collaborating with cross-functional teams to analyze safety data and prepare comprehensive safety reports. I am passionate about enhancing patient safety initiatives and providing training to colleagues, which has been instrumental in fostering a culture of compliance and excellence within the organization.