New Cairo, Cairo, Egypt
With five years of experience in drug safety and pharmacovigilance, I am confident in my ability to contribute to the safety monitoring and regulatory compliance in all aspects of Pharmacovigilance and Quality Management Systems. My experience in Quality Management Systems has allowed me to effectively integrate QMS principles into my work in Pharmacovigilance, ensuring that all processes are in compliance with applicable regulations and company-designated regulations. As a certified ISO 9001 QMS lead auditor, I have the practical experience in document Management, SOPs drafting and updating, Deviation management, CAPAs, risk analysis for planning audit, Auditor in various internal and external audits (not limited to pharmacovigilance), . Support in audit and inspection readiness. I've also strong background in regulatory affairs with CTD Module 1.8.1, 1.8.2, 2.5 and 5 preparation and SmPC/PIL preparation. As an associate alumni of Harvard Medical School, I've studied the essentials of epidemiology and biostatistics. Also. I am familiar with HTA basics and pharmaceconomic modelling. I am passionate about contributing to public health through my work in Pharmacovigilance and Quality Management Systems, and I am always looking for new opportunities to learn and grow in these fields.
https://alketaba.com/author/mahmoud-naguib/
Military Service "mandatory"