仕事概要
職種 | 専門職(コンサルタント、金融、不動産、専門サービス)/専門サービス(医療、福祉、教育、インストラクター) |
---|---|
業種 | 医療/ その他医療 |
雇用形態 | 未分類 |
ポジションレベル | その他 |
募集人数 | 1名 |
希望入社時期 | - |
必須語学力 |
英語 (ビジネスレベル) 日本語 (流暢に話せるレベル) |
活かせる語学 | - |
勤務時間 | その他 |
福利厚生・休暇 | |
ビザ取得支援 | - |
外国人従業員 | - |
仕事詳細
Company Overview
Pharmaceuticals Company
Job Description
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
Requirements
・ 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)
面接について
連絡先
PV Senior/Specialist
RGFタレントソリューションズ株式会社
800 〜 1100 万円