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）
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The role involves collecting and assessing safety information of pharmaceutical products, compliance with regulations, audit contributions, and project participation for global safety processes.
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.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
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.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
Top Skills
Global Safety Database
Medical Writing
Pc Skills
Safety Database
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