- 非公開 No.AI190315
- ＜Medical Monitoring＞
1．Primarily acts as back-up Medical Advisor but may serve as Regional Medical Advisor on assigned projects.
2．Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
3．May contribute to the medical review of the protocol, Investigative Drug Brochure (IDB) and/or Case Report Forms (CRFs).
4．May provide therapeutic area/indication training for the project clinical team.
5．Attends and may present at Investigator Meetings.
6．Performs review and clarification of trial-related Adverse Events (AEs).
7．May perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department.
8．May provide medical support for the Analysis of Similar Events (AOSE), in collaboration with or on behalf of Pharmacovigilance department.
9．May perform medical review of adverse event coding.
10．Performs review of the Clinical Study Report (CSR) and patient narratives.
11．Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
12．Available 24 hours per day, 7 days per week to respond to urgent protocol-related issues at the investigative sites.
・Obtain Japanese MD licence.
・Clinical Experience in Oncology-Urology in Japan.
・Japanese Skill: Native in reading, writing, hearing, and speaking.
・English Skill: Business level in reading and writing. Hearing and speaking in business level prefer but willing to study is also acceptable in hearing and speaking area only.