Nada Ibrahim Email & Phone Number

Cairo, Cairo Governorate, Eg

Review of safety reports and forms received from partners and Ensure that they are processed on timeContinuous monitoring of communication received at partners to ensure the detection and assuring the proper management of initial safety reports/FU info Assuring that all communication with partners are properly archived and all information are trackedGeneric email monitoring and quality check Setting up database for PV regulations through screening authority websites and list of local journals for several countriesAffiliate Report SIMPL for signal management checking for products under RAY management

Participate in preparation and regular update of RAY PV SOPsParticipate in preparing Pharmacovigilance training slides for Clinical operation team, patient support program, contracted third party as required. Prepare Aggregate reports as PBRERs and their national appendix and addendum to clinical overview (ACO) as well as (RMPs), according to the regulatory obligations and timelines. Participate in management of spontaneous and solicited safety ICSRs including signal management as per the company/MAH and regulatory obligations and submitting them as per regulatory timelinesParticipate in reviewing and reporting adverse events and serious adverse events for clinical trials under management of RAY to the Sponsor and/or MOH as applicable as per timelines.Prepare Literature review weekly for the MAH (global MAHs as well) products as a stand-alone services and perform quality checks n Participating in screening EMEA authority websites, general and several specific journals for several global projects/MAH PV Team leader for several Sponsors’ Patient Support Programs: Providing PV trainings for team members, handling safety and product complaint reports received and ICSR’s weekly and monthly reconciliations and quality checks

Establishing and maintaining a pharmacovigilance system.Create, conduct, and continuous updating PSMF/PSSFFocal point in communication with regulatory authorities and sponsorsProviding health authorities with any information relevant to product safety Ensuring conduct of pharmacovigilance and submission of all pharmacovigilance-related documents in accordance with the legal requirements and Good Vigilance Practices (RMP, ACO, PBRER/PSUR, ICSRs) Review changes to existing products and SOPsHaving an overview of the safety profiles and any emerging safety concerns for the contracted MAH’s products

Backup/Deputy for Project ManagerKeeping the project manager informed of task accomplishment, issues, and statusManage, follow up, and report every activity performed from PSP team Reviewing the written reported adverse events for products & product technical complaints filled by patient educator /patient tele educator to the sponsor's Relevant departmentAssuring that the team members have the necessary education and training to effectively participate on the team.Assuring that the team addresses all relevant issues within the specifications and various standards.

Responsible for handling or managing patients’ medical records while ensuring patient health information confidentiality and security.Performing pharmacovigilance activities, confirming recording and reporting of adverse events.Patient education through enhancing patients’ knowledge