With eleven years of expertise in pharmacovigilance, I have managed end-to-end pharmacovigilance operations, medical assessment, routine safety evaluation, and the establishment of PV system set-ups at both affiliates and global offices. As a people manager, I have led teams to achieve global compliance standards and thresholds. My experience includes handling various safety databases, managing data migrations, conducting database validations, and performing quality reviews of safety medical data. I specialize in managing pharmacovigilance projects for clinical safety, covering innovator biotech products and biosimilars from study initiation to life cycle safety management (phase IV and routine PV activities). I have processed and reviewed Individual Case Safety Reports (ICSRs), and prepared and reviewed aggregate reports (PBRER/DSUR/PADERs/ASSR/ASR/aCO), including Risk Management Plans (RMPs). Additionally, I have conducted signal management activities with a comprehensive understanding of all regulatory classes, facing multiple regulatory inspections and audits. I have conducted several PV audits, including those for vendors, licensing partners, and affiliates. My experience extends to the complete development and maintenance of Pharmacovigilance System Master File (PSMF), Pharmacovigilance System Summary (PSS), and Pharmacovigilance System Specification File (PVSF). I bring expertise from both the pharmaceutical industry (sponsor) and the contract research organization (CRO), managing PV projects from end to end. I am well-versed in LSMV and PV Automation.
Highlights of my career include serving as the Qualified Person for Pharmacovigilance (QPPV) and receiving the International Young Scientist Award for 2021. I am a representative from the Middle East for the International Society of Pharmacovigilance (ISoP). Additionally, I am a registered Alternative Medicine practitioner (chiropractor) with registration number MD1162.
I am a scientific writing professional with over 15 scientific articles published in international journals.