The Senior Medical Director works with an international team of medical monitors and safety officers to ensure the medical/clinical integrity and quality of studies conducted by Pharm-Olam are conducted in compliance with all applicable competent authority regulations and international Good Clinical Practices (GCP). To serve as the medical contact in study protocols to investigators and study sites team regarding protocol compliance issues and safety of the subjects enrolled. Advises and assures investigators, project teams, and clients on safety issues arising from medicinal products, devices and study designs undertaken by Pharm-Olam. Work with internal team members, senior management and business development on issues and questions of any medical /clinical nature. Reviews SAEs, SUSARs and AEs reports in accordance with all applicable competent authority regulations and ICH E2 reporting standards. Ensure that protocols, investigator’s brochures, clinical trial reports written by Pharm-Olam are appropriately reviewed and approved in accordance with Pharm-Olam’s SOPs and good medical practices.
This is a full-time opportunity for an experienced Medical Director.