エージェント求人

●Manager / Senior Manager, Safety

年収非公開

楽天メディカル株式会社

東京都世田谷区

募集要項選考・企業概要

職務内容

職種

医薬品PMS/製造販売後調査
医薬品PV/安全性情報担当

仕事内容

医薬
SOP管理
内部監査
安全性研究
GVP
SOP作成
QC/Quality Control
安全性評価

【Position Summary】 The Manager/Senior Manager, Safety will support pharmacovigilance (PV), quality control, and vendor oversight activities with respect to the individual case safety report (ICSR) management process at Rakuten Medical. 【Key Duties and Responsibilities】 ●Support ICSR case processing or oversight of vendor activities within the safety database and other systems according to company policies and procedures. ●Create Risk Management Plans, Aggregate Reports (e.g. Periodic Safety Update Report). ●Support management of GVP SOP, and other key PV regulatory documents. ●Participate in the development and implementation of process and procedures to ensure ICSR case processing complies with health authority guidance and regulations (PMDA). ●Manage departmental and company training requirements ●Support internal audits and inspections to ensure accurate information is provided as needed ●Lead and/or address quality control activities such as deviation identification, documentation, and Corrective Action Preventative Actions (CAPA) management related to the ICSR process ●Responsible for interdepartmental collaboration, such as, but not limited to Quality and Regulatory to ensure alignment on procedures, shared deliverables, and goals ●Collaborate with other functions to create aggregated reports and safety documents to support risk management such as drug safety reports, due diligence, approval filing activities, SOPs, and policies ●Participate in the Project team such as Clinical trial, Device development and support other functions to proceed the project ●Manage safety activities in local clinical studies ●Other duties as assigned

求める能力・経験

SOP管理
内部監査
安全性研究
GVP
規制当局動向調査
SOP作成
安全性評価
規制当局交渉

【Desired Education, Skills and Experience 】 ●Bachelor’s degree or higher in a life science related field or Health Care Professional (Nurse, Pharmacist, or physician) preferred ●3+ years of experience of pharmacovigilance in the pharmaceutical or medical device Industry ●Strong organizational skills and ability to meet deadlines ●Working knowledge and experience of ICSR processing preferred ●Regulatory knowledge is preferable (ICH Guidelines, FDA safety regulations, EMA regulations, and other applicable regulatory guidance documents) ●Business level English (Writing, Reading, and Speaking)

語学: 英語でネイティブレベルで会話可能、英語でビジネス会話が可能、英語で日常会話が可能
学歴: 大学院（博士）、大学院（法科）、6年制大学、大学院（その他専門職）、大学院（修士）、大学院（MBA/MOT）、4年制大学