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）
Pfizer is hiring a [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） for a remote role open to applicants in Japan. Level rates it ; you can apply on Pfizer.
Level's read on this job
- Level rates this role Little AI ●○○○: aI is not part of the work.
- This is listed as a remote role.
- The posting mentions pharmacovigilance, safety data management and medical writing among its tools and skills.
- Level classes it as a junior role.
- Pfizer has 622 other open roles on Level.
AI in this role
Collect and assess safety information and adverse events while managing data in the global safety database.
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
How we rate this
[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） at Pfizer rates 0 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.
Little AI. AI is not part of the work.
- ●●●● Builds AI80 to 100
- ●●●○ Works on AI60 to 79
- ●●○○ Uses AI40 to 59
- ●○○○ Little AI0 to 39
Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.
Prepare for this job
Built from this posting and from similar jobs on Level.
Skills and AI tools this role asks for
Questions you could be asked
- Tell me about a project where pharmacovigilance was part of your work. What did you do?
- Tell me about a project where safety data management was part of your work. What did you do?
- Tell me about a project where medical writing was part of your work. What did you do?
Adapt your resume
- List these exact terms on your resume: Pharmacovigilance, Safety Data Management, and Medical Writing. An applicant tracking system matches the wording, not the idea.
- Attach one line of real, concrete experience to at least one of them. A tool named with nothing behind it rarely survives a human read.
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