MA/ Medical Advisor:眼科医、Ophthalmologist


部署 MA
仕事内容 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.

勤務地:品川&大阪 &在宅相談可(出張の対応が可能な方)


必須  Obtain Japanese MD license
Clinical experience as ophthalmologist in Japan. (Board certified ophthalmologist is prefer but not must)
※ No need to have GCP based clinical experience.
 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
 Be able to travel to site and other.

 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。
 出張対応が出来る方


待遇 【給与】経験・能力・資格等考慮し、弊社規程に則して決定します。
【昇給】 年1回(4月)
【賞与】 年2回(6月・12月)、業績賞与(3月)
【諸手当】 時間外手当、通勤手当、外勤手当(CRA職等)

※ 契約社員の場合は一部異なりますので、ご応募頂いた際に個別にご説明致します。