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東京都の臨床開発・薬事の求人136件応募資格・募集要項・仕事内容を見る
Pharmacovigilance Scientist
- 給与
- 記載なし
- 勤務地
- 東京都中央区
- 休日
- 完全週休２日制（土曜・日曜）
- 雇用形態
- 正社員
どんな仕事かAIによる生成
The Pharmacovigilance Scientist supports the Japan Safety Officer and/or Global Safety Officer, with primary responsibility for signal detection and case series data analysis under their guidance. The role supports safety monitoring and assessment, signal evaluation, risk management, preparation of safety reports, and related PV team activities for assigned products.
この求人に応募
応募資格
必須
- Bachelor's degree with related health science background preferred or clinical pharmacy experience strongly preferred. Candidates lacking the preferred experience or appropriate Bachelor’s degree but with previous pharma experience may be considered.
- Two years PV experience or associated field (i.e., regulatory, clinical development, medical affairs) or relevant clinical practice experience is required.
- Understanding of ICH/FDA/PMDA PV related regulations and guidelines affecting drug safety issues.
- Core understanding of safety signaling activities.
- Experience with safety surveillance analysis.
- Must be proficient with technology (Windows, Word, Excel, Outlook, PowerPoint). Proficiency in MS Teams and SharePoint desired.
- Proficiency in English language, both oral and written, to support working in global environment.
- Ability to communicate and present ideas both orally and in writing.
募集要項最終確認 10/11
- 職種
- 臨床開発・薬事
- 雇用形態
- Employment Class: Permanent期間の定めなし試用期間原則なし
- 給与
- 記載なし
- 給与の詳細
- ①基本給：当人の経歴・技術・技能等を考慮して決定②裁量労働制の場合：裁量労働手当として職務グレードに応じて50,000～100,000円支給③フレックスタイム制の場合：月間の所定労働時間を超えて勤務する時間に対して時間外勤務手当を支給有り有り
- 手当
- 裁量労働手当50,000～100,000円住宅手当通勤手当
- 勤務地
- 東京都中央区 アステラス製薬 日本橋事業所 本社
- 働き方
- At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home.Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
- 勤務時間
- 8:45～17:45（Mon～Thu）、8:45～16:00（Fri）Discretionary Work System
- 休日・休暇
- 完全週休２日制（土曜・日曜）祝日5月1日夏季年末年始年次有給休暇育児休業制度介護休業制度
- 福利厚生
- 共済会制度社宅制度持株会制度財形貯蓄制度
- 社会保険
- 雇用保険、労災保険、厚生年金、健康保険
- 業務の変更の範囲
- 会社内での全ての業務
- 就業場所の変更の範囲
- 会社の定める事業場および自宅
- 経験年数
- 2年以上
- 学歴
- 大学卒業以上
- 選考の流れ
- 書類選考 → 1次面接 → 2次面接 → 最終面接※変更の可能性もございますので、予めご了承下さい。CV screening → First interview → 2nd Interview → Final interview*Please be advised that there might be a change in the process.
- 掲載日
- 2026/10/11 09:00（2日前）
- 最終確認
- 2026/10/11 19:20（2日前）
仕事内容
募集の背景 / Purpose & Scope
- The purpose of the Pharmacovigilance Scientist (PVS) role is to support the Japan Safety Officer (JSO) and/or Global Safety Officer (GSO), or other PVSs, as applicable, with primary responsibility for signal detection and case series data analysis under the guidance of the JSO/GSO.
職務の内容 / Essential Job Responsibilities
- Act as key member of the PV Product Responsible team for his/her assigned products, and under the close supervision of the JSO/GSO, the PVS will:
- Collaborate with the JSO, GSO, or other PVSs, as applicable, in coordinating medical-scientific monitoring and assessment of the safety profile of one or more Astellas products.
- Assist JSO, GSO or other PVSs, as applicable, with the preparation of meeting materials/presentations for PV product meetings such as but not limited to:
- Product Responsible Teams
- Core Clinical Development and Core Medical Teams
- Global Development Safety Management Teams
- Joint Safety Management Teams
- Core Teams (Extended)
- And Global Medical Affairs Core Medical Team
- The PVS may also, as requested, attend these meetings with the JSO/GSO.
- The JSO/GSO owns the strategic priorities and drives implementation, while the PVS supports and contributes as necessary applying knowledge of Therapeutic Area, regulatory science, and signal surveillance to manage characterization of the compound/product safety & benefit-risk profile.
- Supporting the JSO/GSO, as applicable, in the development of the initial safety surveillance development strategy and leading subsequent updates to this strategy;
- Performing with the first level safety signal detection and signal evaluation activities (e.g., safety database and literature review, health authority queries) for Astellas products, and finalizing these assessments in conjunction with the JSO/GSO and/or other PVSs.
- Support the JSO/GSO, or other PVSs, as applicable, for inspection /audit readiness activities and CAPA commitments.
- Under the direction and supervision of the JSO/GSO, or other PVSs, provide guidance and support to Medical Writing vendors in developing key deliverables by actively participating in working sessions to create timely deliverables, share perspectives, and suggest improvements such as:
- Support the vendor, contribute to risk management activities of assigned products, including preparation of the Risk Management Plans (RMP) and execution of risk management strategies in collaboration with internal and external stakeholders.
- Collaborate with the vendor and contribute in the preparation of the relevant signal and risk evaluation sections of the PSUR and DSUR.
- Perform the creation of JP local periodic reports including J-PSUR, J-DSUR, Re-examination Application document, etc., and J-RMP.
- Support the drafting of revisions to the RSI section and expected events list for the IB in conjunction with risk evaluation during DSUR preparation and/or signal evaluations.
- Ensure the accuracy, quality, and timeliness of all assigned responsibilities and tasks
- Assist with data requests, document preparation and/or review of data.
- If requested, support the Drug Safety Assistant with activities such as meeting scheduling, meeting minutes, and tracking of adherence to deliverables.
この求人は、アステラス製薬株式会社の採用ページの内容をAIが読み取って整理したものです。応募の前に採用ページの原文を確かめてください。データの集め方企業サイト
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募集元の採用ページから応募できます
応募はアステラス製薬株式会社の採用ページで受け付けています。このページは採用ページの掲載内容をもとに構成しているため、最新の応募条件は募集元でご確認ください。
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