medical advisor/眼科:外資系医薬品関連会社 (~1700万円) in 大阪府

posted
job type
正社員
salary
¥ 10,000,000 年棒
apply now

job details

posted
location
大阪府
job category
医薬品・医療機器
job type
正社員
salary
¥ 10,000,000 年棒
reference number
55038-27
apply now

job description

社名
社名非公開

職種
医薬品

業務内容

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. 



求められる経験
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。
※GCPでの臨床経験は必要なし

給与
年収1000 ~ 1700万円

skills

・日本の医師免許
・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。
・出張対応が出来る方