Role at a glance
- Salary
- Not Disclosed
- Location
- Tokyo, Japan
- Work arrangement
- Hybrid
- Employment
- Full-time
- Experience
- ファーマコビジランス業務や安全性データマネジメント業務の経験（尚可） / Experience of Pharmacovigilance and/or Safety Data Management (preferred) • メディカルライティングの経験・スキル（尚可） / Medical writing experience/skill (preferred) • 安全性データベースに関連した業務経験がある（尚可） / Experience relating to Safety Database
- Education
- 薬剤師等の医療関連資格を有するもしくは理系出身者 / Medical qualification (e.g. Registered Pharmacist) or Science background at colleague or above
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Role Summary
Supports case management for safety information concerning marketed products and investigational drugs in the Japan Drug Safety Unit. The role involves collecting and assessing adverse-event information, managing safety records, and supporting regulatory compliance and global safety processes.
What You'll Do
- Collect and assess adverse-event safety information for marketed products and investigational drugs.
- Enter and manage data in the global safety database.
- Support compliance with regulations in Japan, the United States, and Europe, and maintain safety compliance.
- Contribute to domestic and overseas internal audits and regulatory inspections.
- Respond to queries concerning individual case safety reports.
- Contribute to projects developing global safety business processes.
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
PC skills; fluent Japanese sufficient to understand and explain Japanese regulations and prepare regulatory documents in Japanese; medical qualification (e.g. registered pharmacist) or science background at college level or above; English verbal and writing skills with TOEIC score more than 600 required. The posting also calls for practical problem-solving, outcome-oriented judgment, meeting departmental quality standards while achieving personal goals, and teamwork.
Required
- PC skills
- Fluent Japanese language capability to understand and explain Japanese regulations and prepare regulatory documents in Japanese
- Medical qualification (e.g. Registered Pharmacist) or science background at college or above
- English verbal communication and writing skills; TOEIC score more than 600
Preferred
- Pharmacovigilance and/or safety data management experience
- Medical writing experience or skill
- Experience relating to a safety database
- TOEIC score more than 730
Original job description
Content provided by the employer
Original job description
Content provided by the employer
１．主な職務における成果責任/ Description of 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．応募資格/ Qualifications
【スキル要件 / Skill requirements】
• PCスキル / PC skill
• ファーマコビジランス業務や安全性データマネジメント業務の経験（尚可） / Experience of Pharmacovigilance and/or Safety Data Management (preferred)
• メディカルライティングの経験・スキル（尚可） / Medical writing experience/skill (preferred)
• 安全性データベースに関連した業務経験がある（尚可） / Experience relating to Safety Database
【職務経験 / Background requirement】
• 日本語能力（日本語で日本の規制を理解し、説明することができる。規制当局向けの文書を日本語で作成することができる。） / Fluent Japanese language capability (able to understand and explain Japanese regulation in
Japanese, able to develop regulatory documents to be submitted in Japanese.)
• 薬剤師等の医療関連資格を有するもしくは理系出身者 / Medical qualification (e.g. Registered Pharmacist) or Science background at colleague or above
• 建設的に日常の課題を見つけ、解決できる / To be able to find and solve challenges points in daily work practically and constructively
• 結果を見据えた判断ができる / To make a decision with good expectation of outcome of the decision
• 部門に求められる業務水準を満たした上で、個人の目標を達成することができる / To achieve personal goals in addition to fulfilling quality level of work required in the department
• チームで働くことができる / To be able to work as a team
• 英会話及び英語ライティングスキル （TOEICスコア 600点以上（必須）、730点以上（尚可）） / English verbal communication and writing skill (TOEIC score more than 600 (must), or more than 730 (preferred))
【勤務地 / Location】
東京本社 / Tokyo Headquarter
※応募時は、日本語・英語両方の応募資料の提出をお願いします。 / Please submit application form in both Japanese and English.
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
Medical
About the company
Pfizer
Large Enterprise
Pfizer is a global biopharmaceutical company dedicated to the discovery, development, and manufacturing of innovative healthcare solutions. With a strong focus on improving lives through medications and vaccines, Pfizer has played a significant role in addressing various health challenges, including infectious diseases, chronic illnesses, and rare conditions. The company emphasizes research-driven approaches and collaborative efforts in its mission to enhance global health and empower patients through cutting-edge science and technology. Through its commitment to high standards of safety and efficacy, Pfizer continues to shape the future of medicine.