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就業場所: Tokyo, Kanto
賃金: ご相談可能
雇用形態: Permanent
言語: English > Business Level, Japanese > Native
サブカテゴリ―: Pharmaceuticals
職種: Healthcare R & D

会社概要

Pharmaceuticals Company

仕事内容

research and analysis and reporting on the events, adverse events during the occurrence
- Timely reporting to regulatory authorities (individual cases, various periodic reports)
, timely adverse event reporting to headquarters, detection of safety signals and trend changes
, compliance with industry and internal rules for all medical activities, Thorough maintenance / improvement of compliance with Japanese domestic regulatory requirements and headquarters rules
The following operations are added depending on experience
・ Development of drug risk management plan, monitoring and review of PDCA cycle after formulation
・ Application for deadline of re-examination application items
・ Others, investigation to secure safety including past cases, Analysis, report planning, implementation

応募資格

・ Knowledge of pharmacovigilance (3 years or more, individual case evaluation experience)
・ Pharmaceutical Affairs Law, GVP / GPSP ministerial decree and related work knowledge
・ Basic medicine, pharmaceutical Knowledge
・ Risk management
・ Compliance
・ information gathering, analytical ability
・ English ability (reading and writing required, TOEIC 700 points or more is more acceptable)

その他情報


試用期間: 3
受動喫煙: yes
時間外労働: yes
加入保険: yes
休日: weekend
就業時間: 10:00 AM - 6:00 PM
休憩時間: 12:00 PM - 1:00 PM

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