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
Global Pharma Maker
Job Description
• Provide leadership and management of Japan PV group, ensuring timely and appropriate service levels and compliance with Clinigen Group’s contractual and regulatory obligations
• Responsible for the establishment and maintenance of the PV system(s), acting to fulfil responsibilities as a Marketing Authorizsation Holder (MAH)
• Support global PV to ensure that they can meet their regulatory obligations
• Influence the performance of Japan’s GQP as it relates to pharmacovigilance activities and to promote, maintain and improve compliance with the legal requirements of Pharmacovigilance
• Ensure the information contained in Japan’s GVP is an accurate and up-to-date reflection of the pharmacovigilance system
• Maintain oversight of and ensure Japan and global Pharmacovigilance regulatory compliance
• Oversee and enable the addition of new products into the Pharmacovigilance System, in collaboration with and after approval of the global PV for such admissions
• Ensure appropriate management of Safety Data Exchange Agreements (SDEA) with global PV
• In collaboration with Quality, ensure the creation, maintenance and operation of the PV System Audit plan
• Approve Risk Management Plans, PMS plan and report, Aggregate Reports (e.g. Periodic Safety Update Report), GPV SOP, and other key PV regulatory documents
• Oversees and ensures compliance with the companies post-marketing PV regulatory commitments
Requirements
• Extensive (5-10 years) experience of Pharmacovigilance in the Pharmaceutical or service Industry
• Scientific or medical degree
• Experience in Line Management
• Leadership skills, ability to coach and develop others and to act as a catalyst for positive change
• Demonstrated ability to influence
• Experience in unlicensed medication a plus
• Fluent in written and spoken English with strong verbal and written communication skills
• Experience in developing SOPs, RMPs and other PV documents
• Expert knowledge of Japan and global pharmacovigilance regulations and guidance
• Ability to travel
面接について
連絡先
PV Manager
RGFタレントソリューションズ株式会社
1200 〜 1400 万円
