Experienced Pharmacovigilance individual with 10 years in the pharmaceutical industry with a passion for managing Product safety towards a clear goal: Patient and Consumer Safety. *Ensures the efficient operation of processes relating to receipt and processing of safety information from all sources, the quality and integrity of all safety data, the distribution of ICSRs and regulatory reports, in full compliance with all PV legislation. *Possess a good working knowledge of pre- and post-marketing Pharmacovigilance, skilled in communication, REMS/RMP, DHCP, PSUR, SDEA, CAPA’s, teamwork , quality auditing, PSMF management, literature screening, oversight of vendors and SOP writing. * Well versed with Arab, SFDA, EU, USFDA, UAE guidelines.* Dealing with all PV requirements of major regions like MENAT, Africa, CIS, Far East and EU.* Proficient in working with safety Databases (Argus 8.0) and MedDRA, WHO drug coding. * Preparation of dossiers, eCTD management, renewal and variations submissions.* Responding to all unsolicited medical queries, entry and tracking into medical information databases, maintaining the library of standard responses.* Experienced in content management systems like Veeva Vault.* Was involved in PSP, POP studies of major oncology products.* Majored in Pharmacology, Toxicology and Immunology studies in pre clinical & clinical trials.