PV Specialist

1- Assist in the maintenance of the Pharmacovigilance System of the company including all activities which contribute to the detection, assessment, understanding and communication of safety information and to ensure that any emerging safety concern or adverse reactions is detected and reported to the PV department, in order to be evaluated.
2- Assist in the maintenance of the company’s compliance with respect to ICSRs reporting.
3- Act as a contact point for the Pharmaceutical Vigilance General Administration (PVGA) in the Egyptian Drug Authority (EDA) on a 24-hour basis to ensure business continuity and also as a contact point for pharmacovigilance inspection. 
4- Handling and reporting of ICSRs in the appropriate format to the PVGA, in compliance with the timelines.
5- Performing literature searches and obtaining literature articles and reviews, to guarantee up to date information.
6- Preparation and submission of all PV related documents to PVGA, including but not restricting to Risk Management plan (RMP), Periodic benefit Risk Evaluation Report (PBRER), Addendum of clinical overview (ACO), etc.
7- Preparation and submission of other PV documents to PVGA, including but not restricting to Emerging Safety Issues, Signals, etc.
8-   Assist the QPPV in the preparation for the PV audits/inspection including the development and maintenance of documents, and implementation of CAPA.
9-   Giving trainings for the company’s employees and partners about pharmacovigilance,   handling and reporting of ICSRs.
10- Having awareness of post- authorization safety studies requested by EDA