Mohy El-Din Ismail
Compliance and Pharmacovigilance Consultant at Insight - Egypt- Claim this Profile
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Experience
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Insight - Egypt
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Egypt
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IT Services and IT Consulting
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1 - 100 Employee
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Compliance and Pharmacovigilance Consultant
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Sep 2017 - Present
- Compliance and PV Safety Consultant for many national and multinational companies, including Aspen (UAE), Lavasta (UK), Spimaco (SA), Besins Healthcare (France), and more.- Apply (EU) GVP in safety projects across the country regarding oncology medications and Biologics including COVID-19 Vaccines.- Establish and develop E2B electronic safety communication platforms comply with WHO E2B (R3) and E2B (R2)- Oversight the full Pharmacovigilance outsourcing process (PVO), and transfer the execution of drug safety functions and processes smoothly to a third-party service provider (Insight Co.).- Lead Insight company team to audit, and assess the status of pharmacovigilance in pharmaceutical companies, including key players, activities, strengths, and challenges of the current pharmacovigilance system of MAHs.- Identify contextual factors that could positively act as barriers toward the GVP in the current pharmacovigilance system of MAHs.- Develop situational analysis reports outlining short- and long-term recommendations and safety variations which contribute to strengthening the current pharmacovigilance system of MAHs. Show less
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Project Manager of Vigipx Safety Database
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Jul 2019 - Present
Project Manager of the Vigipx safety database for ICSRs processing and quantitative analysis of aggregate reports, providing the structure, process, and system outputs in accordance with ICH E2B and GVP.https://www.insipx.com/vigipx
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Clavita Pharma
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Egypt
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Regulatory Affairs Director
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2017 - 2021
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AUG Pharma
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Egypt
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Pharmaceutical Manufacturing
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400 - 500 Employee
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Senior Regulatory Affairs Responsible
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2016 - 2017
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Ministry of Health & Population - Egypt
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Egypt
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Government Administration
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700 & Above Employee
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Minister's Office Operations Management
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2014 - 2016
- Quality Assurance and Descriptive statistics preparation for media and press releases. - Crisis Management and Strategic Planning. - Quality Assurance and Descriptive statistics preparation for media and press releases. - Crisis Management and Strategic Planning.
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Egyptian Drug Authority
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Egypt
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Pharmaceutical Manufacturing
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500 - 600 Employee
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Compliance Section Head
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2012 - 2016
Managing the Registration Cycle and Technical Processes for Pharmaceutical Products Licensing and Authorization. Managing the Registration Cycle and Technical Processes for Pharmaceutical Products Licensing and Authorization.
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Misr Pharmacies
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Egypt
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Pharmaceutical Manufacturing
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200 - 300 Employee
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Customer Relationship Management Analyst
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2011 - 2013
Building and maintaining profitable relationships with pharmacy customers. Resolving customer complaints. Participate in customer loyalty program which keeps customers updated on the latest products and services in order to increase the total sales. Building and maintaining profitable relationships with pharmacy customers. Resolving customer complaints. Participate in customer loyalty program which keeps customers updated on the latest products and services in order to increase the total sales.
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El Ezaby Pharmacy
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Egypt
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Pharmaceutical Manufacturing
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700 & Above Employee
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Pharmacist
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Jun 2010 - Jan 2012
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Education
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Modern Sciences and Arts University
Bachelor's degree, Pharmaceutical Sciences, Pharmaceutical Sciences