Soha Abd Elshakour Email & Phone Number

Cairo, Cairo Governorate, Eg

- Finalizing PV software in cooperation with IT team in order to send ICSRs as XML file as requested by the National authority and acquiring EPVC approval.- Implementing Internal application to send ICSRs by sales team to PV team- Managed a team of pharmacovigilance personnel- Fulfilling QPPV role along with the national requirements- Establishing new digital channels for ICSRs reporting through company website- Creating tracking system to monitor PV activities, documents and requirements- Achieved more than 95% of Final PV approvals for the registration/ re-registration of the company products

Cairo, Egypt

- Ensuring the readiness for the internal audit and external inspection- Training of PV and non-PV Personnel- Overview of medicinal products safety profiles and any emerging safety concerns- Creating and updating the required PV SOPs/WIs- Review and approval of SDEA with other vendors and parties- Ensuring the implementation of the Post Marketing activities- Ensuring quality management system and compliance in place- Ensuring submission of all Pharmacovigilance-related documents in accordance with the legal requirements of the Egyptian GVP

Egypt

- Completing the necessary documents and certificates such as DOC, FSC, CE, FDA , 14 “S” and Agency Agreement- Preparation and submission of technical file to the National Authority.- Registration of the Sterile Medical Devices, Disinfectants and Antiseptic products- Acquiring the Importation approvals- Follow up with the foreign suppliers from Europe, USA, Mexico and Canada till sending the exact document and certificates- Follow up the post marketing incidents as per Medical Devices Vigilance Guidelines- Collect the reports regarding complaints on medical devices and make the appropriate actions

Egypt

- Preparation of tablets and capsules till delivery to packaging section.- Preparation and packaging of sachets and veterinary products.- Follow up compression of tablets and filling of capsules on the machines.- Delivery of finish veterinary products to warehouse.- Completing Batch Production Records.- Making the necessary additional or return or deviation reports.- Preparation of S.O.Ps- Preparation of Semisolid dosage forms.- Internal Auditor inside the Company.

Diploma, Clinical Pharmacy

Bachelor, Pharmacy