Pfizer
[JDSU] 医薬品安全性統括部 ケースマネジメントチーム（一般社員） （Staff, Case Management, Japan Drug Safety Unit）
Be an Early Applicant
The role involves collecting and assessing safety information, managing data on a global safety database, ensuring compliance with regulations, responding to regulatory queries, and contributing to global safety process projects.
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
#BI-Hybrid
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
#BI-Hybrid
Similar Jobs at Pfizer
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
The MAS role involves providing medical and scientific leadership, ensuring high standards of communication with stakeholders, executing medical plans, and addressing unmet medical needs in assigned therapeutic areas. Responsibilities include collaborating with healthcare professionals and executing organizational goals through scientific exchanges and strategic planning.
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Supports Pfizer’s Japan medical communications and content strategy across therapeutic areas. Responsibilities include adapting global scientific content, developing local materials, coordinating medical channel strategies, ensuring regulatory compliance, managing reviews and approvals, producing KPI reports, and overseeing vendors, budgets, timelines, and deliverables. The role requires strong scientific communication, publication, digital channel, stakeholder management, and bilingual Japanese-English capabilities within a pharmaceutical Medical Affairs environment.
Top Skills:
Digital AnalyticsDigital Compliance SystemsDigital Platforms
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Serves as Pfizer Japan’s medical and scientific expert for breast cancer, partnering with healthcare professionals, medical societies, regulators, academia, and internal teams. Develops and executes medical plans, identifies unmet needs, supports clinical development, generates evidence, manages advisory boards, communicates scientific data, gathers stakeholder insights, and ensures compliance, patient safety, and appropriate product use.
What you need to know about the Singapore Tech Scene
The digital revolution has driven a constant demand for tech professionals across industries like software development, data analytics and cybersecurity. In Singapore, one of the largest cities in Southeast Asia, the demand for tech talent is so high that the government continues to invest millions into programs designed to develop a talent pipeline directly from universities while also scaling efforts in pre-employment training and mid-career upskilling to expand and elevate its workforce.
