Melissa Bernal

Background

About Melissa Bernal

Vicepresident of the Colombian Pharmacovigilance Association Co-chair Ecopharmacovigilance SIG ISoP As an experienced Pharmacovigilance Specialist, I possess a strong working knowledge of FDA, Health Canada, and EMA regulations/guidelines with respect to clinical safety and GMP. With over five years of hands-on experience, I have maintained an efficient vigilance system in compliance with health regulations and quality management systems. I am a healthcare professional with a Master´s degree in epidemiology, and I have exceptional attention to detail and the ability to collaborate with internal and external stakeholders to ensure compliance. Throughout my career, I have demonstrated a proven ability to provide training and ongoing support, perform quality assurance and quality control for work delegated to global vendors, and address issues. I have authored and developed documents related to pharmaceutical and cannabis-based products for NCA marketing authorizations in different countries. I have also conducted post-market surveillance and managed adverse event reporting in compliance with current regulations. As a self-starter with excellent verbal and written communication skills, I am able to work independently and collaborate effectively with teams. I possess excellent conflict resolution skills and am highly organized, which allows me to effectively manage multiple tasks and projects simultaneously.