Develop safety management plans and oversee serious adverse event case management from intake to regulatory reporting.
Perform intake, triage, data entry, medical coding, and narrative composition for individual case safety reports.
Provide safety training, review standard operating procedures, and assist clients with safety-related reviews.
Precision Medicine Group is a global contract research organization specializing in clinical research and drug development services. The company fosters a collaborative culture and offers competitive benefits to support employee growth.
Process individual case safety reports (ICSRs) for clinical trials and post-marketing programs.
Ensure accurate data entry, coding, and query resolution in the Argus Safety Database.
Collaborate with cross-functional teams to meet regulatory reporting requirements and maintain compliance.
Precision Medicine Group is a global life sciences company specializing in precision medicine and drug development services. They employ thousands of professionals and emphasize a collaborative culture.
Support the Quality Management System including SOPs, training, and CAPA processes.
Coordinate and conduct internal audits, vendor audits, investigator site audits, and trial master file audits.
Provide QA consultation and support to project teams, and manage quality issues and corrective actions.
Precision for Medicine is a Clinical Research Organisation that combines novel clinical trial designs with advanced biomarker and data analytics solutions. The company has a strong focus on rare diseases and oncology, with a global team and a culture that values employee contributions and collaboration.