Pharmacist
El- DEMRDASH Hospital
Total years of experience :12 years, 0 Months
-Responsible for the establishment and maintenance of the Pharmacovigilance system within the company, and ensure that the system is in compliance with the EPVC regulations and the GVP guidelines.
-Preparation and submission of Risk Management Plans (RMPs) requested by the Egyptian Pharmaceutical Vigilance Center and Health authorities.
-Responsible for collecting, handling and submitting Individual Case Safety Reports (ICSRs) to the Egyptian Pharmaceutical Vigilance Center (EPVC) and Health authorities within the defined time frames.
-Preparation and submission of Periodic Safety Update Reports (PSURs) to the Egyptian Pharmaceutical Vigilance Center according to European & Egyptian guidelines.
- Conducting training to all the company personnel who are involved in the Pharmacovigilance activities .
-Assessment, Validation & Reporting of any adverse drug reaction suspected to be related to any of the company medications to EPVC and Health authorities .