Medhat Mahfouz
Head Of Pharmacovigilance at Zeta pharma- Claim this Profile
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Arabic Native or bilingual proficiency
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English Professional working proficiency
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French Elementary proficiency
Topline Score
Bio
Credentials
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Qualified Person for Pharmacovigilance
EPVC - Egyptian Mininstry of Health
Experience
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Zeta Pharma
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Egypt
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Pharmaceutical Manufacturing
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200 - 300 Employee
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Head Of Pharmacovigilance
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Aug 2020 - Present
- Development of the pharmacovigilance section in the company, and put the scope for its work. - Maintainance of Pharmacovigilance System Master File (PSMF) - Training the company stuff on Pharmacovigilance work. - Access regularly on the published newsletters, which are published on the pages of pharmacovigilance on the web - The establishment of work rules in the management of pharmacovigilance according to the guidelines of EPVC and the rules of GMP. - Follow-up Statistics for doctors to identify the needs of the yellow cards to monitor the products and their side effects and recording the results of its study - Follow-up the preparation of studies and research , and guide the development of individuals scientifically and practically on the latest global guidelines and the reports of similar drugs for other companies - Responsible for setting the scope of the work of pharmacovigilance management for other departments , which in contact with , for helping pharmacovigilance on his work to the fullest - Responsible for ICSR and Continuous monitoring of the safety profile of authorized medicinal products (product specific risk management systems) and PV planning: Signal detection and review, Risk-benefit assessment, Reporting and communication notifying EPVC and HCP of changes to the risk-benefit balance of products. - Responsible for Pharmacovigilance activities, monitoring of safety profile , Signal detection and review - Be responsible for Periodic Safety Update Reports (PSURs) - Updating the safety profile of the product according to Emerging safety issues - Keeping the SmPC for the products up to date. - Using MedDRA coding for various safety information. - Preparing scientific files for the products according to the last most updated safety and efficacy data. - Preparing Pharmacoeconomic files. Show less
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Head of Pharmacovigilance Department
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Sep 2015 - Jul 2020
- Establishment of the pharmacovigilance section in the company, and put the scope for its work. - Put and development of Pharmacovigilance System Master File (PSMF) - Training the company stuff on Pharmacovigilance work. - Access regularly on the published newsletters, which are published on the pages of pharmacovigilance on the web - The establishment of work rules in the management of pharmacovigilance according to the guidelines of EPVC and the rules of GMP. - Follow-up Statistics for doctors to identify the needs of the yellow cards to monitor the products and their side effects and recording the results of its study - Follow-up the preparation of studies and research , and guide the development of individuals scientifically and practically on the latest global guidelines and the reports of similar drugs for other companies - Responsible for setting the scope of the work of pharmacovigilance management for other departments , which in contact with , for helping pharmacovigilance on his work to the fullest - Responsible for ICSR and Continuous monitoring of the safety profile of authorized medicinal products (product specific risk management systems) and PV planning: Signal detection and review, Risk-benefit assessment, Reporting and communication notifying EPVC and HCP of changes to the risk-benefit balance of products. - Responsible for Pharmacovigilance activities, monitoring of safety profile , Signal detection and review - Be responsible for Periodic Safety Update Reports (PSURs) Show less
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ARAB DRUG CO. (ADCO)
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Egypt
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Head of Pharmacovigilance & Senior Quality Analyst
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Jul 2014 - Sep 2015
- Access regularly on the published newsletters, which are published on the pages of pharmacovigilance on the web- The establishment of work rules in the management of pharmacovigilance according to the guidelines of EPVC and the rules of GMP and the development of detailed description of pharmacovigilance system(DDPS)- Follow-up Statistics for doctors to identify the needs of the yellow cards to monitor the products and their side effects and recording the results of its study- Follow-up the preparation of studies and research , and guide the development of individuals scientifically and practically on the latest global guidelines and the reports of similar drugs for other companies- Responsible for setting the scope of the work of pharmacovigilance management for other departments , which in contact with , for helping pharmacovigilance on his work to the fullest- Responsible for ICSR and Continuous monitoring of the safety profile of authorized medicinal products (product specific risk management systems) and PV planning: Signal detection and review, Risk-benefit assessment, Reporting and communication notifying EPVC and HCP of changes to the risk-benefit balance of products.- Responsible for Pharmacovigilance activities, monitoring of safety profile , Signal detection and review- Be responsible for Periodic Safety Update Reports (PSURs)- Performs instrumental analysis (UV, HPLC) of in-process and finished products,and (HPLC,IR) of raw materials.Performs physical testing and chemical analysis of pharmaceutical packaging material. Troubleshoots and resolves operations issues. Prepares and standardizes volumetric solutions, reagents and indicators internal calibration of instruments according to work instructions. Validation of the assay methods of finished products. Participates in validation of facilities and manufacturing processes.Training the new employers on the working in chemical and instrumental labs. Show less
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QC Microbiologist
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Sep 2013 - Jun 2014
Supervise and perform tests on various microbiological activities on a regular basis. Maintain knowledge on various testing methods and perform all manual operations on various supplies. Develop and maintain validation in all protocols for various environmental controls. Perform laboratory analysis on all materials after appropriate sterilization. Perform tests on component samples, identify any contamination and perform analysis for appropriate source for same and initiate corrective actions. Perform various culture of micro organisms in isolation according to standard inhibition and ensure controls over moisture and temperature. Monitor all physiological and morphological characteristics and identify micro organisms. Perform tests on all incoming ingredients and documents all records. Develop and prepare documents for all protocols. Perform audit on various environmental program and perform review for same. Develop various testing processes for all raw materials and equipments and monitor all finish products. Investigate all issues and prevent any GMP problems on samples. Maintain accurate records and perform tests on all activities conducted in laboratory. Develop and documents various microbiology laboratory processes and prepare final reports. Maintain purchase orders for all laboratory processes and monitor inventory for same. Show less
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Pharmacovigilance Specialist
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Mar 2012 - Jun 2014
- Access regularly on the published newsletters, which arepublished on the pages of pharmacovigilance on the web- The establishment of work rules in the management ofpharmacovigilance according to the guidelines of EPVC and therules of GMP and the development of detailed description ofpharmacovigilance system(DDPS)- Follow-up Statistics for doctors to identify the needs of theyellow cards to monitor the products and their side effects andrecording the results of its study- Follow-up the preparation of studies and research , and guidethe development of individuals scientifically and practically on thelatest global guidelines and the reports of similar drugs for othercompanies- Responsible for setting the scope of the work ofpharmacovigilance management for other departments , which incontact with , for helping pharmacovigilance on his work to thefullest- Responsible for ICSR and Continuous monitoring of the safety profile of authorized medicinal products (product specific risk management systems) and PV planning: Signal detection and review, Risk-benefit assessment, Reporting and communication notifying EPVC and HCP of changes to the risk-benefit balance of products.- Responsible for Pharmacovigilance activities, monitoring of safetyprofile , Signal detection and review- Be responsible for Periodic Safety Update Reports (PSURs): Thepreparation, processing, quality control, review and reporting.- Responsible for all administration documents to be secure andconfidential Show less
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QC Specialist
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Jan 2011 - Jul 2013
Performsinstrumental analysis (UV, HPLC) of in-process and finished products,and (HPLC,IR) of raw materials.Performs physical testing and chemical analysis of pharmaceuticalpackaging material. Troubleshoots and resolves operations issues.Prepares and standardizes volumetric solutions, reagents andindicators internal calibration of instruments according to workinstructions. Validation of the assay methods of finished products.Participates in validation of facilities and manufacturing processes Show less
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Pharmacist
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Jul 2009 - Jan 2011
Provided prescribed medications, drugs, and other pharmaceuticals. Dispensed and handled record-keeping of controlled substances. Effectively managed conflict to achieve desired business results. Worked with other members of the pharmacy to ensure accuracy of prescriptions, Filled prescriptions for customers, Assisted in clerical and logistical tasks Managed stocks and supplies. Interpreted information and recommended solutions Provided prescribed medications, drugs, and other pharmaceuticals. Dispensed and handled record-keeping of controlled substances. Effectively managed conflict to achieve desired business results. Worked with other members of the pharmacy to ensure accuracy of prescriptions, Filled prescriptions for customers, Assisted in clerical and logistical tasks Managed stocks and supplies. Interpreted information and recommended solutions
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Education
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2005 - 2009
Ain Shams University
B.Sc. of Pharmacy
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