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東京都の臨床開発・薬事の求人230件応募資格・募集要項・仕事内容を見る
Senior Specialist or Manager, Pharmacovigilance, Oncology
- 給与
- 記載なし
- 勤務地
- 東京都
- 休日
- 記載なし
- 雇用形態
- 正社員
どんな仕事かAIによる生成
This position leads a team of PV operations in day-to-day operations and compliance activities to maintain PV systems across the assigned region. Responsibilities include PV system oversight, ICSR management, periodic safety reporting, audits and inspections, risk management, safety monitoring, launch readiness, and safety review of assigned research protocols.
この求人に応募
応募資格
必須
- A minimum of 2 years’ experience required within the pharmacovigilance or a related field.
求める人物像
- Effective communicator and able to work effectively in teams and a cross functional environment.
- Strong commitment to compliance with relevant rules and procedures. • Effective planning and organizational skills, and the ability to complete activities with high quality.
募集要項最終確認 11/4
- 職種
- 臨床開発・薬事
- 雇用形態
- Full-time
- 役職
- Senior Specialist or Manager
- 給与
- 記載なし
- 勤務地
- Minato City, Tokyo
- 働き方
- 記載なし
- 経験年数
- 2年以上
- 掲載日
- 2026/10/13 06:28（23日前）
- 最終確認
- 2026/11/04 20:04（1日前）
仕事内容
Purpose
- This position is accountable for executing the day-to-day operations and compliance activities by leading a team of PV operations to maintain high-functioning PV systems across assigned region remit. Reports directly to Japan PV Operational Lead.
Metrics and Oversight of the Pharmacovigilance System
- Supports the provision of metrics that will ensure oversight of all aspects of the performance and functioning of the PV system in compliance with local regulations and internal company timelines/standards.
ICSR Management
- Records, processes, and conducts follow up and translates adverse events and other safety information from spontaneous and solicited sources.
- Performs ICSR expedited reporting according to the local requirements.
- Ensures local-language medical or scientific literature review.
- Implements an appropriate local quality control (QC) procedure to ensure quality of information entered and report decisions.
- Completes AE reconciliation and ensures AE identification effectiveness sampling consistent with global procedures.
Periodic Safety Reporting
- Ensures submission of periodic safety reports and ensures documentation of evidence.
Audits and Inspections
- Actively assists in managing internal PV audits, audits of affiliate service providers/third parties and Regulatory Authority PV Inspections.
Partnership with business partner with possibility for identification and/or handling of safety information
- Ensuring all PV requirements are in place for activities where there is a reasonable possibility for the identification and/or handling of safety information in accordance with AbbVie procedures and local requirements.
Risk Management (if applicable)
- Collaboration with Safety Science is essential for the following tasks. Do refer to the DOP and JPN GL 04, which are defined separately, for more details.
- Develops a deep knowledge of the Risk Management Plans (RMPs) to obtain information on the risk/benefit profile of products, for implementation of EPPV locally.
- Liaises with affiliate safety science and where applicable, during development or revision of the COUNTRY RMP (if applicable)
Safety Monitoring
- For EPPV, understands and monitors incoming local safety data and communicate changes or potential concerns to the affiliate safety science, for evaluation.
Launch Readiness
- Collaborate with Safety Science and along with Safety Control Manager to ensure the successful launch of new drugs/additional indications in Japan by executing a solid local strategy to ensure local regulatory compliance.
Affiliate Review Process for research
- Review the assigned TA and products Reg-PMOS protocols from a safety perspective.
この求人は、アッヴィ合同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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