You will be responsible for overall safety information management both domestically and internationally. Details: - Monitoring domestic cases and supporting the instruction to MR for re-investigation. - Primary evaluation of clinical trial and post-marketing safety information in Japan, as well as literature conference evaluations. - Primary evaluation and translation of foreign (English) safety information using CIOMS, Med Watch forms, and literature conference information. - Work on English translation (creation of CIOMS, Med Watch, Annual reports, etc.). - Preparation and SGML encoding of reports for adverse drug reactions/infections to PMDA, research reports, measures reports, and defect reports. - Monitoring conference literature/homepages for regular infection reporting, preparation of regular infection reports. - Preparation of regular safety reports, PSUR, and PBRER drafts. - Consultation on and management of safety information work overall and related tasks.
The above information is a public job ad. This job ad is neither an offer nor a contract.
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