davidnjoroge65510

About: I am a pharmacist with over ten years of experience in clinical safety, pharmacovigilance, and regulatory oversight of medicines and clinical trials in Kenya, the European Union, and across Sub-Saharan Africa. My work has focused on the safety and ethical conduct of clinical research, including protocol safety review, SAE and SUSAR oversight, benefit–risk assessment, and aggregate safety evaluation through DSURs, Investigator’s Brochures, and Clinical Study Reports. I have supported safety planning and operational oversight for clinical trials, reviewed GCP inspection findings, and worked closely with regulators, sponsors, CROs, and safety physicians to ensure compliance with national legislation, GCP, and WHO standards. My background combines frontline clinical practice in Kenya’s public health system with senior regulatory and pharmacovigilance leadership, allowing me to assess clinical trials not only for scientific rigor, but also for participant protection and public health relevance.