Melissa Bernal
Qppv @Phv Latam
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WORK HISTORY
Qppv @Phv Latam
Case processing of SAEs and other events subject to regulatory reporting in accordance with SOPs and E2B standards within established milestones. • Quality control of safety documents developed by other stakeholders, such as patient narratives, causality assessments, and aggregate reports.
EDUCATION
Universidad del Rosario
Graduate Certificate, Translational Medicine
Universidad del Rosario
Graduate Certificate, Metabolism, Biological Drugs and Auriculomedicine
Universidad del Rosario
Doctor of Medicine (MD), Medicine
Harvard T.H. Chan School of Public Health
Principles and Practice of Clinical Research, clinical research, Post-graduate Program
Universidad del Rosario - Universidad CES
Epidemiologist specialist, Epidemiology
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.
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