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
• Planning and conducting PMS activities for Medical products
• Manage the relationship with Pharmacovigilance providers and internal personnel
• Contribute to the development, production, and maintenance of the appropriate tracking and compliance tools, reports, plans, tasks and activities pertaining to the management of the pharmacovigilance activities
• Support and/or draft regulatory inquiry responses related to pharmacovigilance/safety issues to regulatory agencies, EC/IRB, Investigators, and ad hoc inquiries
• Provide input and review to key regulatory or clinical documents (i.e., clinical study reports, investigator brochures, integrated summaries of safety, DSUR, etc.) related to pharmacovigilance
• Participate in internal global pharmacovigilance meetings as well as joint safety meetings with partners if needed
Requirements
• Minimum five (5) years in PMS in pharmaceutical industries setting with both investigational and marketed products
• Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments (including ICH/CIOMS, Clinical development methodology and knowledge of Clinical Trial guidelines (GCP) and regulation) is essential
• Practical examples of end-to-end project management within Drug Safety/PV or relevant experience
• Active participation in regulatory inspections is a plus
• At least two (2) years of experience with, aggregate safety reporting, safety surveillance, signal management and/or Risk management
面接について
連絡先
PMS Manager
RGFタレントソリューションズ株式会社
1000 〜 1300 万円
