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
• Authorship of aggregate safety reports (e.g., J-PSR, UNADR, J-DSUR) with minimum supervision.
• Authorship of J-Risk Management Plan (J-RMP) for J-NDA and post-market updates (including associated documents, e.g. additional pharmacovigilance plan and risk minimization tools) with minimum supervision.
• Authorship of responses to regulatory agency / external stakeholders regarding simple safety enquiries (Responses to query; RtQ).
• Authorship of Early Post-marketing Phase Vigilance (EPPV) protocol with general condition, and authorship of EPPV interim and final reports with minimum supervision.
• Authorship of J-GVP related parts of Re-examination dossier for responsible marketed products with minimum supervision.
Requirements
Note: The following represent common education and experience but not mandatory requirements.
- Typically requires a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a health science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline (e.g. biology, chemistry, or neuroscience).
- Shows proficiency in verbal and written communication, including Microsoft Excel, Word, and Power Point.
- Shows good analytical thinking skills, attention to detail, teamwork, initiative, and basic project management skills; maintains confidentiality; maintains meticulous attention to project deadlines.
面接について
連絡先
Manager, Risk Management
RGFタレントソリューションズ株式会社
800 〜 1300 万円
