M Khaled

Pharmaco Vigilance Specialist

• Job Details:Support management of patient safety operational processes at country organization in ensuring compliance with global/local procedures, national and international regulations/standards/guidelines for pharmaco vigilance. Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all products from clinical trials, non-interventional studies, patient oriented programs, literature, spontaneous reports, etc. Manage reporting/submission/distribution of safety reports/updates/information to local health authorities and/or clinical operations in cooperation with other country organization departments. Interact and exchange relevant safety information with local health authorities, patient safety associates, other functional groups and third-party contractor, if applicable. Survey and monitor national pharmaco vigilance regulations and provide update to global patient safety organization. Develop, update and implement local procedures to ensure compliance with patient safety global procedures and national requirements. Input, review and approval of program proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information. Management and maintenance of all relevant patient safety databases. Ensure that relevant local literature articles are screened as appropriate. Develop and update training materials for pharmaco vigilance and ensure training of country organization associates on relevant patient safety procedures for AE reporting, including field force and third-party contractor, if applicable. Ensure support for and close-out of audits, corrective action plan, investigation and health authority inspections. Manage and maintain efficient patient safety filing and archive system. Review of all phase IV clinical trial and NIS protocols safety sections and if a contract research organization is conducting the trial, review the contract, train the contract research organization associates responsible from the trial.

Pharmaco Vigilance Specialist

• Job Details:Drives the local execution of the risk management plans for all products ensures training on risk management plans principles and product specifics of country organization staff involved in the implementation. Supports the drug safety responsible in the timely and compliant execution locally of the pharmaco vigilance activities defined in the risk management plans. Preparation of RMP, ACO, PBRER folders of company products.

Dispensing Pharmacist

• Job Details:Prescribe OTC medicines to the patients, provide the right drug to the right patient, provide medical advice to the patient, train fresh graduated employees.