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新着求人 メディカルドクター  (MD-28)
募集職種 外資系CROの Medical Advisor/眼科
勤務地 東京&大阪 &在宅相談可(出張の対応が可能な方)
会社概要 非公開
求人要件 採用人数:1名
Medical Monitoring:
・ Primarily acts as back-up Medical Advisor but may serve as Regional Medical Advisor on assigned projects.
・ 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.
・ May contribute to the medical review of the protocol, Investigative Drug Brochure (IDB) and/or Case Report Forms (CRFs).
・ May provide therapeutic area/indication training for the project clinical team.
・ Attends and may present at Investigator Meetings.
・ Performs review and clarification of trial-related Adverse Events (AEs).
・ May perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department.
・ May provide medical support for the Analysis of Similar Events (AOSE), in collaboration with or on behalf of Pharmacovigilance department.
・ May perform medical review of adverse event coding.
・ Performs review of the Clinical Study Report (CSR) and patient narratives.
・ Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
・ Available 24 hours per day, 7 days per week to respond to urgent protocol-related issues at the investigative sites.
資格: 日本の医師免許
経験: 日本での眼科医としての臨床経験。学会認定眼科専門医の資格があれば好ましい。
日本語力: 読み、書き、ヒアリング、スピーキングともに母国語レベル
英語力: 読み、書きともにビジネスレベル。ヒアリング、スピーキングもビジネスレベルが好ましいが、これから頑張る方でも大丈夫です。
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