Staff, Case Management, Japan Drug Safety Unit

Staff, Case Management, Japan Drug Safety Unit Pfizer Inc.

Pfizer Japan Drug Safety Unit – Staff, Case Management

1. Primary Role & Responsibility A. 市販製品・治験薬の安全性情報（有害事象）収集、評価 / Collection and Assessment of safety information (adverse event information) of marketed/investigation Pfizer products B. グローバル安全性データベースへのデータ入力と管理 / Data entry and management on Global Safety Database C. 日米欧の法規制の遵守、安全性コンプライアンス維持 / Compliance with laws and regulations of Japan, the United States and Europe, and maintenance of safety compliance D. 国内、海外の社内及び規制当局の査察・監査対応 / Contribution to domestic and foreign internal audit/regulatory inspection E. 個別安全性情報における照会事項対応 / Response to regulatory query regarding to Individual Case Safety Report F. グローバル安全性業務プロセスの構築に係るプロジェクトへの参画 / Contribution to projects relating to development of process relating to global safety

2. Qualifications

Skills

• PC skill
• Experience of Pharmacovigilance and/or Safety Data Management (preferred)
• Medical writing experience/skill (preferred)
• Experience relating to Safety Database (preferred)

Background:

• Fluent Japanese language capability (able to understand and explain Japanese regulation in Japanese, able to develop regulatory documents to be submitted in Japanese.)
• Medical qualification (e.g. Registered Pharmacist) or Science background
• Able to find and solve challenges practically and constructively
• Ability to make decisions with expected outcomes
• Able to achieve personal goals in addition to department quality standards
• Able to work as a team
• English communication and writing skills (TOEIC score more than 600 (must), or more than 730 (preferred))

Location

Tokyo Headquarter

Assignment: Hybrid