Responsibilities

The Pharmacovigilance Specialist will be responsible for receiving and triaging safety information, assigning numbering, performing content verification, inputting data into databases, conducting initial assessments for PMDA reports, and performing QC. They will also create and QC explanation texts (in both Japanese and English), prepare and QC reports for submission to the PMDA, conduct investigations (queries) to obtain additional information, detect and evaluate signals from domestic and international literature and overseas measures, input data into databases and QC, and create reports for submission to PMDA. Additionally, the role involves preparing draft safety reports, infection reports, and annual reports, as well as creating line lists for clinical trial sites, and collaborating with various stakeholders including customers and clinical trial facilities.