Jobs list of Pharmaceutical & Pharmacovigilance

ファーマコビジランス

治験薬に関する包括的な安全対策業務経験がある方必見です。

6 - 10 million yen Osaka Pharmaceutical Pharmacovigilance

Company overview: We are a global pharmaceutical company that develops, manufactures and globally markets a wide variety of pharmaceutical products. We are particularly strong in the areas of gastrointestinal, cardiovascular, central nervous system, immunology, and other disease areas, providing innovative medical solutions. We promote sustainable medical innovation to improve the health of patients and the quality of healthcare. The company is also committed to social responsibility by focusing on community involvement and sustainable corporate activities. Through aggressive investment in research and development, as well as product development from a global perspective, the company contributes to the advancement of healthcare around the world.
Responsibilities: 日本における臨床試験に関する安全性業務臨床試験における安全対策立案と関連文書の作成・レビュー
グローバル開発チームのPV担当との折衝・情報共有
治験薬に関する安全性評価（個別症例評価ではない）
治験薬の安全性に関わる文書の作成（治験年次報告書等）
承認申請における安全対策立案（添付文書「使用上の注意」、RMP等）、審査対応

日本における承認後の安全対策に関する業務市販直後調査
安全性情報のシグナル／リスク評価・安全対策立案（添付文書「使用上の注意」、RMP等）
安全性定期報告等の定期報告書の作成
再審査申請における安全性評価

グローバル安全性評価チームにおける安全性評価、安全対策立案等

【大阪／PV】プロジェクトマネージャー

安全性情報管理経験者必見です!

6.2 - 15 million yen Osaka Pharmaceutical Pharmacovigilance

Company overview: We are a global healthcare company and the largest provider of biopharmaceutical development and commercial outsourcing services. In today\'s rapidly changing environment surrounding the healthcare industry, we are making a significant contribution to the development of the industry through its four business segments: Clinical Development, Sales & Marketing, Investment & Alliances, and Consulting. The company, which has supported the development and commercialization of the top-selling drugs worldwide, plans to substantially increase the number of CRAs as it continues to increase projects in large-scale global studies, the anticancer field, the central nervous system field, and other rheumatology fields.
Responsibilities: プロジェクト成果物を管理する。
プロジェクトにおける日々の顧客対応をリードする。
プロジェクト計画（タイムライン、成果物）、スコープ、品質、収益を管理する。（収益管理には、財務システムの更新、売上確認、請求、予算のレビュー、財務分析、チェンジオーダーの対応などを含む）
KPI（売上、コスト、利益）をオーバーサイトし、財務面のパフォーマンスを担保する。
SOPや過去のベストプラクティスに基づき、プロジェクト開始時における潜在的リスクの特定や、稼働後リスク軽減策を実施する。
内外の関係者との会議をリードする。
プロジェクトステータスの情報更新や、プロジェクトの戦略を策定する。
顧客とのパートナーシップを形成し、良好で強い関係を維持する。
顧客のロイヤルティと契約更新を注視し、新しいビジネスチャンスを協議する。
国内外とのステークホルダーとの円滑な関係性を構築し、業務遂行する。

【東京】ラインマネージャー（安全性部門／市販後PJT）

※在宅ベースで働きやすい環境

8 - 14.5 million yen Tokyo Pharmaceutical Pharmacovigilance

Company overview: We are a global healthcare company and the largest provider of biopharmaceutical development and commercial outsourcing services. In today\'s rapidly changing environment surrounding the healthcare industry, we are making a significant contribution to the development of the industry through its four business segments: Clinical Development, Sales & Marketing, Investment & Alliances, and Consulting. The company, which has supported the development and commercialization of the top-selling drugs worldwide, plans to substantially increase the number of CRAs as it continues to increase projects in large-scale global studies, the anticancer field, the central nervous system field, and other rheumatology fields.
Responsibilities: PV事業部のオペレーション部門にてラインマネジメントをお任せします。ラインマネジャーはオペレーションスペシャリスト（PVスタッフ）の生産性向上がミッションです。市販後PJTは中国、インドのスタッフとも連携が必要になってくるため、英語を活かして働くことができます（通訳もいるため英語が流暢でなくても挑戦できます）。
■業務内容詳細：
・要員計画、業務配分、業務の指導などを通じて、担当するチーム（10~20名程度）のラインマネジメントを行う。
・メンバーとの定期的なコミュニケーションを通じて、サポーティブで働きやすい環境を実現・維持する。
・メンバーのパフォーマンス評価とキャリア開発を行う。
・他のマネージャーと協力して、プロジェクトのスケジューリング、要員計画、ピーク時のワークロードの予測を行い、プロジェクトの実
情を確認・評価・報告する。
・チームの作業プロセス、手順、およびインフラが継続的に改善されるようリードする。
・成果物の品質、タイムライン、コスト、生産性をモニタリングし、改善をリードする。
・メンバーのトレーニングニーズを特定し、トレーニングプランを策定・展開する。

Medical Doctor - Safety

1st MD position in the company

12 - 18 million yen Tokyo Pharmaceutical Pharmacovigilance

Company overview: We are a global IT services and consulting company that supports business transformation through digital, technology, and consulting services. We provide digital strategy, IT consulting, systems integration, and outsourcing services, aiming to drive industry innovation and efficiency. Additionally, we leverage our global network and advanced technologies to deliver optimal solutions to our clients.
Responsibilities: Perform second level triage workflow, review through the entire source document for any potential serious adverse event/s in the case based on conventions
If the case is serious, then in the activities tab, select the Case level seriousness as Yes
After the review of the case, document the assessment in the same action item, To be retained as Non-serious OR To be upgraded as Serious with respective rationale and close the action item
Inform the respective triage associate via email for upgraded case
Ensuring the ICSR is medically relevant, complete and accurate
Validation of Seriousness criteria, events captured, coding, labeling, Causality assessment, Writing Company / PV comment. Review and finalize Narratives.
Generating medically relevant follow-up questions
Identifying and notifying potential signals

Senior Specialist Quality Assurance / PV Audit

Global Company

8 - 10 million yen Tokyo Pharmaceutical Pharmacovigilance

Company overview: We are a leading life sciences company based in the United States, with a parent company. Our core business revolves around the research, development, importation, manufacturing, and sale of pharmaceuticals and vaccines. Every day, we strive towards our mission and goals by protecting people\'s health and helping them build fulfilling lives. We aim to promptly address unmet medical needs in Japan and globally. Furthermore, we actively engage in activities to promote access to medicines, including product donations and supply to those in need through various programs and partnerships.
Responsibilities: Prepares, conducts QA audits, generates audit reports, communicates results to the relevant QA management and relevant business stakeholders (e.g. Clinical trial team), and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.
Activities may include GCP and/or PV related routine and directed audits of investigator sites, country offices, vendors, regulatory documents and marketing applications, third party/business partner collaborations and due diligence activities.
Participates in the development/enhancement of QA procedures, guidance documents and audit tools to ensure QA consistency globally.
Promotes standardization of auditing approach within QA.
May represent QA as a single point of contact and provide QA guidance for studies in a certain Therapeutic Area (TA) or in certain countries to achieve continuous quality improvement and effective quality assurance.
Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate to provide Good Clinical Practice/Pharmacovigilance QA expertise.
Contributes to the QA strategy and supports QA goals for the aligned studies/countries in the Region.
Proactively identifies analyses and leverages quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to support the implementation of associated risk mitigation strategies.
In alignment with risk assessments, supports the identification of audit substrate for scheduling, as appropriate.
In collaboration with the QAL, actively contributes to the quality management oversight, in the development of clinical risk assessments and quality oversight initiatives (quality plan, quality agreements) as needed.
Support Significant Quality Issues management for assigned studies, including assessment of potential root causes and remediation (corrective and preventative actions) as needed.
Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the QAL, TA Head and line manager.
Provides inspection management support as appropriate.
Develops and delivers awareness sessions with minimal supervision on various GCP and/or PV topics internally and externally.
Acts as a strong technical resource and is called upon to resolve GCP/PV issues based on knowledge of relevant SOPs (Standard Operating Procedures), GCP, PV regulations and guidelines as well as local regulations.

Japan Risk Management Leader

Rich pipeline, both Clinical and PMS

9 - 14 million yen Tokyo Pharmaceutical Pharmacovigilance

Company overview: Our client is a leading global pharmaceutical firm with a presence in about 150 countries and a workforce of around 40,000 employees. The company is dedicated to advancing healthcare through innovative treatments across various therapeutic areas.

In Japan, the firm employs over 2,500 professionals focused on delivering solutions tailored to the specific needs of the local population. By integrating global advancements with local insights, the company collaborates closely with healthcare providers to ensure effective and accessible therapies.

Committed to sustainability and corporate responsibility, the firm strives to improve patient outcomes and enhance the quality of life. Its efforts make significant contributions to both the local and global healthcare landscape.
Responsibilities: ake full accountability to create, implement and verify J-RMP activities including EPPV, risk communication activities and aggregate reporting such as J-DSUR, J-PSUR, Periodic Infection Report and Non-serious unlisted periodic report including reports for medical devices and all activities related to Post-Marketing Surveillance/Clinical study/Database research.
Take full accountability to prepare Re-examination dossier and GPSP compliance inspection in responsible products/compounds.
Lead and manage PvA and PMSO in responsible products/compounds.
Lead and facilitate J-SMT meeting in collaboration with JPKK’s key stakeholders including JCoT members.
As an extended member of Global Safety Management Team(G-SMT), liaise with G-SMT of responsible products/compounds.Join JCoT, NPI and other related committee with license partner companies as a representative for J-SMT of responsible products/compounds and proactively lead safety risk management related discussions and take necessary actions by covering early stage of clinical development though postmarketed phase of products.
Lead and contribute to the prevention and rapid resolution of local safety risk management related issues including timely stake holder management (internal and external) of responsible products/compounds.
Plan and monitor budgets and controls expenditures for responsible products/compounds in collaboration with Group manager/ Director.
Contribute to the implementation of continuous process improvements from advanced safety management point of view by utilizing latest technologyes while enhance sustainable efficiency in collaboration wih SPMD.
Understand the rule and principle of the relevant regulations such as PMD Act., GCP, GVP and GPSP and ensure compliance to those regulations, within own responsibility.

医薬品の安全性管理業務統括（経営職）

グローバル人材を積極的に採用しております。

8 - 12 million yen Tokyo Pharmaceutical Pharmacovigilance

Company overview: We are a leading biotechnology company focusing on cutting-edge technologies. Our key areas of focus include cancer, kidney disease, and immune disorders. In the field of antibody medicine, we are committed to developing innovative new drugs by combining technologies such as the "Potelligent technology" (which enhances antibody activity by 100 times) and "Human Antibody-Producing Mouse." We are dedicated to establishing a global research and development framework to provide medicines to a large number of patients.
Responsibilities: 市販薬および治験薬の安全性情報管理業務統括（RMP策定、安全確保措置の策定と管理、開発プロジェクトへの参画及び臨床研究部門との連携など）
グループ会社担当者（海外含む）と連携した活動（電話会議、メール連絡、海外出張など）
規制当局との対応業務（定期報告作成責務、再審査申請資料作成責務、照会事項、適合性調査対応業務など）

Jobs list of Pharmaceutical & Pharmacovigilance

ファーマコビジランス

【大阪／PV】プロジェクトマネージャー

【東京】ラインマネージャー（安全性部門／市販後PJT）

Medical Doctor - Safety

Senior Specialist Quality Assurance / PV Audit

Japan Risk Management Leader

医薬品の安全性管理業務統括（経営職）

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