Jobs list of Pharmaceutical
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Job number: JN -082025-193070 Posted: 2025-08-25
QA ワクチン・再生医療等製品担当
ワクチン、バイオ医薬品、または新規モダリティ品目の国内品質保証(GQP)の経験が活かせます。6 - 10 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client a major Japanese pharmaceutical company engaged in the research, development, manufacturing, and sales of pharmaceuticals. Our group promotes four business areas—new drugs, generics, vaccines, and OTC products—to meet diverse medical needs. By expanding our operations globally, we aim to provide innovative treatments to a wide range of patients. Additionally, we possess advanced technological capabilities and well-equipped facilities to support our research and development. We actively conduct clinical trials both domestically and internationally, striving to demonstrate leadership in the pharmaceutical industry while emphasizing our commitment to contributing to society as a whole.
- Responsibilities
- 品質課題対応/変更管理/逸脱/品質情報/品質契約/GMP 監査/製造委託先の Data Integrity 維持・向上等
製造委託先等管理業務の推進と業務改善
当局査察の準備推進・製造所の支援
製造委託先等の GMP 向上支援? 当局提出資料（IND/IMPD、CTD、承認申請書、試験報告書等）の信頼性の確保
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -072024-143159 Posted: 2025-08-20
Medical Affairs PM
Medical PM8 - 14 million yen Tokyo Pharmaceutical Medical Affairs
- 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
- 1) In research projects led by companies, manage research projects and contribute to the creation of evidence according to the plan.In the research project, as a member of the study team, in the process of planning, budget management, execution, and publication of results, internal related departments (R & D headquarters, legal / compliance department, purchasing department, finance department, etc.), the US headquarters, and outside the company Collaborate with partners.
In the research planning phase, develop a research timeline and budget plan, and lead the research feasibility assessment.
In the start preparation phase, we will be in charge of a wide range of tasks such as vendor selection, facility selection, various contract creation, and internal regulation assessment, and promote the project so that the research start can be achieved on timeline. In the execution phase, manage the project to proceed as planned through vendor management, cost management, and schedule management. We will also strive to ensure the quality of research.
Work to comply with compliance by conducting research based on ethical guidelines and various laws and regulations and guidelines while coordinating with related departments within the company.
For US headquarters-led research, work with headquarters personnel to promote the project.
2) In collaboration with researchers and their research institutes, the US headquarters, and related departments within the company (Medical Affairs, R & D Headquarters, Legal and Compliance Department, etc.), while maintaining the independence of researchers and the neutrality of research. Manage and execute researcher-led research (IIS) support operations and support the creation of innovative evidence by Japanese researchers.Responsible for researchers / research institutes and US headquarters in collaboration with related departments throughout the entire process of supporting IIS applications, contracting adopted projects, providing research funds and research drugs / compounds, preparing for research start, conducting research, and reporting results. Coordinate / negotiate with other parties and manage / execute IIS support operations.
In the field of cancer where research on new treatment methods is advancing, doctor-initiated clinical trials are also covered by the IIS support system, and if adopted by the examination, research funds and investigational drugs will be provided to provide future new cancer treatments. Support the development of law.
Collaborate / collaborate with related departments within the company to creatively find solutions when introducing an unprecedented new research support system.
Post the latest information on the IIS support system developed by the US headquarters worldwide on an external website, and provide detailed information on the system and procedures to researchers considering application in collaboration with related departments within the company. ..
When making a research contract with a research institution to which a researcher belongs, prepare a draft contract, negotiate a contract, and conclude a contract.
After starting the research, we will confirm the progress of the research (including the status of publication) based on the contract, arrange the provision of research drugs / compounds, and pay the research expenses according to the milestone.
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -082025-192746 Posted: 2025-08-20
QA 国内外製造所管理（第五グループ）
国内外当局査察対応経験、新製品の国内外申請業務の経験、製造所の GMP監査経験がある方必見です。6 - 10 million yen Kanagawa Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client a major Japanese pharmaceutical company engaged in the research, development, manufacturing, and sales of pharmaceuticals. Our group promotes four business areas—new drugs, generics, vaccines, and OTC products—to meet diverse medical needs. By expanding our operations globally, we aim to provide innovative treatments to a wide range of patients. Additionally, we possess advanced technological capabilities and well-equipped facilities to support our research and development. We actively conduct clinical trials both domestically and internationally, striving to demonstrate leadership in the pharmaceutical industry while emphasizing our commitment to contributing to society as a whole.
- Responsibilities
- 国内外に展開される商用医薬品・治験薬における品質マネジメント推進
製造委託先管理業務としての品質課題対応/変更管理/逸脱/品質情報/品質契約等の対応並びにGMP向上のサポート
海外当局査察にむけた Inspection Readiness の推進・製造所の支援
当局提出資料(IND/IMPD、CTD、承認申請書、試験報告書等)の信頼性の確保(文書監査)
海外グループ会社を含めた社内関係各部所と連携し、製品(治験薬及び商用医薬品)安定供給の推進
製造所等のGMP/GDP監査
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -082025-192760 Posted: 2025-08-20
PJマネジメント担当
製薬企業、または化学品製造企業での、PJマネジメント、CMO管理等の経験をお持ちの方必見です8 - 14 million yen Tokyo Pharmaceutical Research & Development
- Company overview
- Our client a major Japanese pharmaceutical company engaged in the research, development, manufacturing, and sales of pharmaceuticals. Our group promotes four business areas—new drugs, generics, vaccines, and OTC products—to meet diverse medical needs. By expanding our operations globally, we aim to provide innovative treatments to a wide range of patients. Additionally, we possess advanced technological capabilities and well-equipped facilities to support our research and development. We actively conduct clinical trials both domestically and internationally, striving to demonstrate leadership in the pharmaceutical industry while emphasizing our commitment to contributing to society as a whole.
- Responsibilities
- ①抗体製造用セルバンクに関する各種業務(ロット切替、保管場所選定等)の全体マネジメント、及び需給管理②標準品等に関する需給管理③海外グループ会社での原薬・製剤製造サイト立ち上げPJへの参画④海外グループ会社への原薬・製剤製造委託窓口⑤製剤二次包装サイト選定・立上げPJマネジメント
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -082025-192755 Posted: 2025-08-20
管理担当
製薬企業でのQA、RA、CMO管理等の業務において、市販後CMC変更管理に関わる業務経験をお持ちの方必見です11 - 15 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- Our client a major Japanese pharmaceutical company engaged in the research, development, manufacturing, and sales of pharmaceuticals. Our group promotes four business areas—new drugs, generics, vaccines, and OTC products—to meet diverse medical needs. By expanding our operations globally, we aim to provide innovative treatments to a wide range of patients. Additionally, we possess advanced technological capabilities and well-equipped facilities to support our research and development. We actively conduct clinical trials both domestically and internationally, striving to demonstrate leadership in the pharmaceutical industry while emphasizing our commitment to contributing to society as a whole.
- Responsibilities
- 市販後CMC変更管理に対する、①製造所等から提案される変更案件のリスト化、および薬事評価要否検討②上記の薬事評価要否検討結果に対する関係部所との協議、合意形成③各変更が最終的に紐づく製剤ロット、および市場出荷時期の可視化④各変更の承認希望時期の設定、および関係部所への情報提供⑤変更案件の薬事対応ステータス、および影響を受ける製剤ロットの確認
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -072024-137824 Posted: 2025-08-19
Medical Manager
Strategy planning and data gathering13 - 17 million yen Tokyo Pharmaceutical Medical Affairs
- Company overview
- We are a foreign pharmaceutical company. Through a merger with an international biopharmaceutical company, we have introduced innovative biotechnology to the Japanese market. Through highly specialized medical information activities, we are enhancing our presence in the Japanese market. Focusing on cancer, cancer immunotherapy, and infertility treatment, we provide innovative healthcare solutions to the people of Japan.
- Responsibilities
- STRATEGY:
Act as Local Medical Affairs TA expert in one or more TAs
Support the Brand or launch teams/ Local TA leadership team in the development of TA, Launch and Brand strategies
Lead Medical Affairs activities in assigned territory along defined local Medical Launch / Brand strategies
Consolidate and communicate trends, market insights, and unmet needs identified in the field
OPERATIONS:
Develop Medical material, review marketing material, trainings
Ensure scientific and clinical accuracy for specific product or brand
Receives adverse event reports and transmits such reports internally according to Company procedures
Ensures timely completion and up-to-date knowledge of Company policies / SOPs, and local laws and regulations
Maintains up-to-date GxP knowledge by following internal and external trainings
Conduct Local internal scientific training and ensure continuous Medical education of existing teams and new employees working in the Local TA
Develop Medical KTL development plans
Positively impact external perceptions and knowledge regarding company and company products
Maintain and demonstrate comprehensive and in-depth scientific TA knowledge when executing assigned tactics
Ensure operational excellence by sharing best practices
Map treatment landscape and medical environment for new indications/ programs
Provide support in the planning and tracking of the (TA-specific) medical budget
DATA GENERATION AND DISSEMINATION:
Lead/ support (depending on nature of study) Medical studies, assist to coordinate Local clinical projects and contribute to site selection for clinical projects
Lead Local publication process, publication dissemination and alignment with Local, Regional and Global publication plan
Act as a resource, liaison and facilitator for ISS and investigators that are aligned to the Medical Affairs strategy
Coordinate with ClinDev and ClinOps in providing field support for research studies and assist in the selection of clinical study sites
Assimilate, process and share medical information with stakeholders
STAKEHOLDER ENGAGEMENT:
Provide training to HCPs and support in realising Medical educational events
Interact with Local stakeholders in Medical community in TA
Identify and interact with influential members of the Medical community (HCPs/external experts) and other healthcare stakeholders (managed care organisations, government organisations, patient groups) within assigned territory and TA
Represent company at Medical Education events, programs, meetings and support patient advocacy related activities
Partner with external stakeholders to develop innovative solutions
Engage with internal colleagues (Medical Affairs department, Clinical Operations, Commercial colleagues as appropriate, etc.) in developing and delivering and participating in Medical or cross-functional initiatives
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -072024-37933 Posted: 2025-08-19
Specialty Care Medical Affairs Lead
Medical Affairs Lead position at global mega-pharma12 - 22 million yen Tokyo Pharmaceutical Medical Affairs
- Company overview
- This company is the world\'s leading pharmaceutical company.
- Responsibilities
- Leadership of medical team, including setting business objectives, performance management and team development
Responsibility for development of the Medical Plan/Strategy for relevant therapeutic areas
Recruitment, development and retention of talented colleagues as well as coaching and guidance of colleagues to support them achieving their maximal potential
Membership of Medical and Commercial Leadership Teams
Resource allocation to ensure appropriate resources to fulfil medical objectives and business needs
Ensure compliance of medical team with country Code of Practice and relevant SOPs, regulations and guidelines
Collaboration with internal stakeholders to ensure timely receipt of information on brand strategy, clinical plan, new clinical data, new regulatory and safety information and accurate, balanced and up to date materials to use in medical to medical communications
Work with key external stakeholders during the life-cycle of the company's medicines, supporting the company strategy and bringing external insights to the organization to shape strategy and providing focused, relevant information in response to their needs
Review and certification of promotional and non-promotional materials and activities and approval of customer engagement programs
Ensure that product materials and related activities reflect the most up to date regulatory labelling and risk management plans and regulatory commitments
Input into regulatory submissions, clinical overviews, license variations and CDS updates as required
Input into HEOR submissions, HTA dossiers, clinical guideline consultations and regional formularies as required
Input into assessment and due diligence of business development initiatives
Support for issues related to supply and distribution, product quality, benefit-risk, market actions and product withdrawals related to portfolio
Support for in country clinical research programs, including protocol and site feasibilities related to portfolio
Protocol approval and oversight of in country non-interventional studies related to portfolio
Support for investigator initiated research (IIR) studies to ensure that appropriate records are kept and progress is monitored
Support for media, government and patient group activities, including policy development, corporate initiatives and issues management
Participate in local, regional and global cross-functional project teams to ensure that ongoing improvements in processes and performance are delivered
Accountable for medical team IIR and headcount/expenses budgets
Represent the country and countries interests to European and Global teams
Yui Osone
Industrial & Life Science -
Job number: JN -082025-192677 Posted: 2025-08-19
【東京】医薬品の開発段階における品質保証（QA）
GQPでの品質保証業務の経験者必見です!7.66 - 12.97 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control
- 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
- バイオ/低分子グローバル治験薬ならびに造血幹細胞遺伝子治験薬に対する品質保証業務（変更管理、逸脱管理、出荷管理、リスクマネジメント、品質情報処理、回収処理、CAPA管理、サプライヤ管理など）
開発段階におけるバイオ/低分子医薬品・医療機器に対する品質保証業務（プロジェクト管理、技術移転、品質契約、委託先製造所の管理など）
グローバル治験薬品質システムの整備
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -082025-192700 Posted: 2025-08-19
Medical Excellence
メディカルアフェアーズ部門における業務経験をお持ちの方必見です6 - 9 million yen Tokyo Pharmaceutical Medical Affairs
- Company overview
- Our client a major Japanese pharmaceutical company engaged in the research, development, manufacturing, and sales of pharmaceuticals. Our group promotes four business areas—new drugs, generics, vaccines, and OTC products—to meet diverse medical needs. By expanding our operations globally, we aim to provide innovative treatments to a wide range of patients. Additionally, we possess advanced technological capabilities and well-equipped facilities to support our research and development. We actively conduct clinical trials both domestically and internationally, striving to demonstrate leadership in the pharmaceutical industry while emphasizing our commitment to contributing to society as a whole.
- Responsibilities
- 下記の職務内容を担当するプロジェクトの実務担当者として、業務を遂行するメディカルプラットフォーム/システム/ツール/デジタルソリューションを構築および維持し、メディカル部門の効率化と生産性向上を推進する
Scientific Engagement活動（Medical Event、Advisory Board Meeting、Medical Booth等）の実施およびサポート
メディカルアフェアーズ機能の適正運営・強化（エクセレンス）
海外グループ会社のメディカルエクセレンス＆オペレーション業務の支援
MSL/メディカルアフェアーズ担当者のcapability強化のため、トレーニング計画を作成/提供する。
海外学会（ESMO-Asia）におけるMedical活動の計画および実施
SOPプロセス、トレーニングの管理
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -082025-192642 Posted: 2025-08-18
プロジェクトマネジメント業務
製薬企業又はCROでPMまたはモニタリングリーダーの経験のある方必見です7 - 10 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- Our Client utilizes imaging technologies such as PET, CT, and MRI to contribute to improving the development efficiency and success rates of pharmaceutical companies.
- Responsibilities
- クライアント要求事項の整理と対応（クライアントとのメイン窓口）
成果物等をクライアントに提供する計画提示
関連部署におけるチームビルディング
プロジェクトのRiskとIssue管理
担当プロジェクトにおける業務範囲の明確化・スケジュール管理と継続した現状分析
社内外におけるStakeholderの特定
プロジェクトの影響範囲と遭遇する諸問題の次善策を検討等
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -082025-192639 Posted: 2025-08-18
【早稲田駅】プラスチック分解プロセス研究※リーダークラス◆経済産業大臣賞受賞スタートアップ
ディレクターといったマネジメントのポジションに進むことも可能6 - 9 million yen Tokyo Pharmaceutical Research & Development
- Company overview
- 微生物のシングルセルゲノム解析技術を用いた受託解析及び共同研究開発
- Responsibilities
- 【世界最大級の微生物遺伝子データベース／2022年大学発ベンチャー表彰 経済産業大臣賞】■業務詳細酵素を用いたプラスチック分解プロセスの研究を担当いただきます。実験計画の立案
微生物培養、遺伝子操作、タンパク質発現・精製、活性アッセイの実施
データ整理・解析・実験ノート管理
部内ミーティングでの進捗共有・技術知見のまとめ
論文・特許・社内及び公的機関への計画書・報告書の作成
■事業内容食品／化学／素材／ライフサイエンスなどの幅広い産業分野において貢献する酵素技術の開発を行っています。
〈事例〉
世界的に関心が高いポリエステル樹脂を分解可能な酵素を同社で開発中です。プラスチック分解酵素をバイオインフォマ技術で探索し、実際に活性が認められた有用な遺伝子の活性向上を実施中です。
■組織構成研究チームは14名程度で組織されており、平均年齢は30代後半と比較的若く風通しがよく、裁量を持って働ける環境です。研究テーマごとに2～3名のチームを組織しています。
■評価制度年2回の人事評価を実施しています。昇給 昇格は評価に応じて、年齢や社歴に関係なく実力主義でアップしていくような設計になっています。
研究者のグレードは5段階あり、ディレクターといったマネジメントのポジションに進むことも可能です。
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -122024-182077 Posted: 2025-08-15
【京都・長岡京】保健士（安全衛生 健康管理スタッフ）◆在宅勤務・フレックスタイム制度有／年休127日
働きやすさ◎＜年休127日・土日祝休・フレックス有5 - 10 million yen Kyoto Pharmaceutical Nurse
- Company overview
- This company is a semiconductor manufacturer.
- Responsibilities
- ■具体的な仕事内容：健康管理室としての産業保健業務を担当いただきます。健康診断、面接指導等の実施及びその結果に基づく労働者の健康を保持するための措置、作業環境の維持や作業管理等の労働者の健康管理に関する指導業務
健康相談やその他労働者の健康の保持増進を図るための措置に関する業務
労働衛生教育や健康教育、健康障害の原因の調査及び再発防止のための措置に関連する内容の業務
健康管理上必要な従業員の情報管理を人事部門と連携し、各種健康診断対象者の選定及び組織管理者展開への支援業務
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -072025-192087 Posted: 2025-08-15
ライセンシング
商談可能な英会話力をお持ちの方必見です6 - 9 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- Our client is a new drug manufacturer.
- Responsibilities
- ライセンス（主にライセンスイン）に関連する業務候補製品、新規プロジェクトの探索
候補製品、新規プロジェクトの初期評価
プロジェクトの事業性評価
提携主要条件交渉、社内外合意形成
海外提携先との窓口業務
社内関連部門とのプロジェクトのコーディネートと推進※当面は実務業務がメインですが、本人の希望や能力に応じ、将来的にはマネジメント業務も検討可能です。
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -052025-188683 Posted: 2025-08-15
Regulatory Affairs Specialist
Tokyo or Osaka OK8 - 10 million yen Osaka Pharmaceutical Regulatory Affairs
- Company overview
- Leading global CRO company
We provide drug discovery, development, lifecycle management and laboratory services.We are a company that provides services related to drug development. We are responsible for the collection and analysis of clinical trial data for pharmaceutical products, support for regulatory filings, and quality control. Our team of experts provides tailored solutions to ensure the safety and efficacy of our clients\' needs. We are focused on providing high quality services in compliance with strict regulations. We provide professional support with our experience and knowledge to help our clients succeed in drug development. - Responsibilities
- Main responsibilities:
Work related to the preparation, maintenance, and management of clinical trial applications and attached documents
Various consultations with regulatory authorities (PMDA, MHLW, etc.)
Work related to approval applications (support for client applications)
Work related to the collection, maintenance, and management of pharmaceutical information
Other (participation in various meetings, training, etc.)
Elaine Montes
Industrial & Life Science -
Job number: JN -082025-192593 Posted: 2025-08-14
プログラムアナリスト
安全性データベース関連業務経験5年以上をお持ちの方必見です5 - 9 million yen Tokyo Pharmaceutical Pharmacovigilance
- Company overview
- Leading global CRO company
We provide drug discovery, development, lifecycle management and laboratory services.We are a company that provides services related to drug development. We are responsible for the collection and analysis of clinical trial data for pharmaceutical products, support for regulatory filings, and quality control. Our team of experts provides tailored solutions to ensure the safety and efficacy of our clients\' needs. We are focused on providing high quality services in compliance with strict regulations. We provide professional support with our experience and knowledge to help our clients succeed in drug development. - Responsibilities
- 安全性DBに関連するエンドユーザーの質問を解決
定期的な辞書の更新をサポート
PV安全性DBベンダーと連携し、システムのアップグレード、機能強化、問題解決
PPD Change Controlポリシーに基づき構成の変更やシステムのアップグレードなど、PV安全性DBへの変更を管理
組み込みツール、OBIEE/SQLを使用し、PV安全性DBからカスタム/アドホックレポートを作成
集積安全性レポートを作成及び検証
PV安全性DBのSOP開発/PV安全性DBの内部および外部監査をサポート
PV安全性DB内に新しいテナントを作成/Distribution Rule Configurationsを開発
データ移管計画、設計仕様、概要レポートの作成を含むデータ移管および検証PJを主導し、データ移管活動が要件を満たし、完全、正確であり、高品質で提供されることを確認
事業の成果や業界のコンプライアンス要件をサポートする為、製品やサービスの開発と提供を組織、調整、文書化し、世界中の部門を超えた徴収に提供する準備をするためイニシアチブのリーダーや経営陣と協力
部門の任務と戦略をサポートするためのサポート資料、プレゼンテーション、ツールを開発
プロセス、システム/アプリケーション、トレーニング、コミュニケーションを開発、最適化、改善するため、イニシアチブのリーダーや経営陣と協力
プロセス改善開発・プロセス改善の取り組みを主導
プロセスの遵守状況を評価しビジネスプロセス改善のニーズに優先順位をつけるために必要な情報を特定し、照合
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -072024-39388 Posted: 2025-08-14
Pharmacoepidemiology Scientist
Position at global mega pharma with very strong pipeline8 - 14 million yen Tokyo Pharmaceutical Data Management / Biostatistics
- Company overview
- We are a global pharmaceutical and clinical research company based in the United States. Through pharmaceuticals, we help people live healthier, healthier, and longer lives. Through productive agreements and partnerships around the world, we have grown to become one of the world\'s leading pharmaceutical companies by expanding its scale and developing pharmaceuticals at low cost. We have many employees who are committed with sincerity in a culture of excellence and are committed to further expansion.
- Responsibilities
- Responsible to lead safety observational studies as scientific lead and to deliver deliverables
Responsible as a study owner of regulatory mandatory safety studies under GPSP (Good Post-Marketing Surveillance Practice)
Demonstrate scientific leadership in safety observational studies, and ensure scientific level of study deliverables from pharmacoepidemiology perspective.
Define research questions, develop study design including statistical analysis plan based on research questions, evaluate and interpretate data (analyze in some cases)
Review and develop study report/publications.
Lead scientific discussion in cross functional team and in discussion with regulatory agency.
Collaborate effectively with global and Japan relevant functions and external partners (investigator, CROs) so as to deliver valuable evidence.
Support non-regulatory mandatory safety observational studies
Provide pharmacoepidemiology expertise to support non-regulatory mandatory safety studies.
Engage in study protocol, study report/publication development and ensure scientific quality from safety perspective in collaboration with relevant stakeholders.
Demonstrate pharmacoepidemiology expertise in safety related activities through product lifecycle
Provide pharmacoepidemiology expertise to support compounds in development, new product launches, and existing marketed products.
Contribute to Japan Risk Management Plan (RMP) development, periodic report development.
Review and develop query response to regulatory authority.
Demonstrate knowledge of relevant global and local regulatory requirements and practices
Understand the roles & responsibilities of the EU Qualified person for Pharmacovigilance (QPPV) and support QPPV to enable to fulfill all QPPV legal responsibilities.
Contribute to organizational RWE capability development
Act as subject matter expert in the development and maintenance of the Safety Quality System and training tools/programs as they relate to pharmacoepidemiology.
Provide pharmacoepidemiology related trainings.
Support system/process development to enhance productivity or increase scientific quality.
Obtain up-to-date pharmacoepidemiology approach/knowledge
Yui Osone
Industrial & Life Science -
Job number: JN -072024-138848 Posted: 2025-08-14
Manager, Bio-Statistician
Global Company10 - 13 million yen Tokyo Pharmaceutical Data Management / Biostatistics
- Company overview
- This company is the world\'s leading pharmaceutical company.
- Responsibilities
- Provide scientifically rigorous statistical input into study design, statistical analysis plans, interpretation of statistical results, project development plans, regulatory issues and scientific and commercialization projects.
Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports (topline reports, clinical study reports, etc.), including clinical trial/PMS results, support for publication activities, scientific presentations, and support to responses to queries from regulatory authority.
Be accountable for study/PMS level and submission level statistical deliverables on assigned projects.
Develop effective collaborations with others within clinical teams, partner lines, external regulatory, industry, professional and academic organizations.
Ensure that all study/PMS and project level statistical activities are conducted in compliance with relevant regulatory requirements and standards.
Be up-to-date on SOP training and compliance with all SOPs as required based on the assigned curriculum.
Provide statistical input and leadership to cross-functional activities – collaborate with other statisticians, data managers, clinical programming colleagues – for assigned studies/PMS and regulatory submissions.
Ensure timeliness and quality of statistical deliverables according to project plans for assigned projects.
Comply with all statistics and quality processes and data standards that are applicable to statistical outputs, and support processes that require statistical input.
Communicate and collaborate with global statisticians on assigned projects.
Provide a strong statistical presence in regulatory and professional circles.
Participate in research on statistical methodology and its applications to clinical trials/PMS.
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -082025-192483 Posted: 2025-08-08
バイオプロセス初期開発
抗体医薬品又はその他バイオ医薬品の製造プロセス開発のご経験をお持ちの方必見です6 - 10 million yen Gunma Pharmaceutical Research & Development
- Company overview
- Our client a major Japanese pharmaceutical company engaged in the research, development, manufacturing, and sales of pharmaceuticals. Our group promotes four business areas—new drugs, generics, vaccines, and OTC products—to meet diverse medical needs. By expanding our operations globally, we aim to provide innovative treatments to a wide range of patients. Additionally, we possess advanced technological capabilities and well-equipped facilities to support our research and development. We actively conduct clinical trials both domestically and internationally, striving to demonstrate leadership in the pharmaceutical industry while emphasizing our commitment to contributing to society as a whole.
- Responsibilities
- バイオ医薬品（抗体及び抗体関連モダリティ）の製造プロセス開発研究（培養もしくは精製）
国内外製造場所への技術移転・委託先管理、治験申請のドキュメント作成
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -082025-192274 Posted: 2025-08-07
免疫研究者
免疫学に関連した探索研究のご経験をお持ちの方必見です7 - 12 million yen Kanagawa Pharmaceutical Research & Development
- Company overview
- We are engaged in the research, development, manufacturing, and sale of pharmaceuticals. We strive to maintain independent management, research, development, production, and sales functions, along with our unique international expansion efforts and the strengthening of our research and development capabilities. Focusing on strategic areas such as "cancer," we are accelerating the creation of promising new drugs, including antibody drugs. We also actively pursue global expansion, aiming to provide high-quality pharmaceuticals and services to patients worldwide.
- Responsibilities
- 免疫学と分子細胞生物学の深い知見に基づき，プロジェクトの非臨床安全性研究を推進する。主として各種のin vitroツールを駆使しながら，安全性に関する課題を特定し，解決策の立案・実行を牽引することで，プロジェクト意思決定と画期的な新薬の創出に貢献する。
医薬品の安全性とヒト予測性の向上に向け，毒性発現メカニズムの解明，新規in vitro評価モデルの構築，新たなバイオマーカーの探索と検証等の先端研究をリードする。
国内外の研究者やビジネスパートナーと連携したグローバルな視点での研究開発を加速させる。
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -052025-187650 Posted: 2025-08-07
Senior Support Analyst / Lead
チームワーク／結果へコミットメントする文化7 - 10 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
- Main responsibilities:
Argus: with Good understanding or experience preferred
Ability to understand and speak Japanese language
Need Will help liaison and interface with Japanese customers for new and existing projects
A Configuration expert, capable of handling configuration activities across various customers across the PVCoE.
Able to contribute across multiple projects.
Good understanding or experience preferred of Argus Safety system and its configurations and backend along with Argus J.
Ability to perform SQL/PL-SQL updates to E2B customizations , pre-post save functions , ACs etc.
In-depth understanding of implementation lifecycle of Safety projects.
Will help in configuration activities across multiple projects in Safety implementation
Experience in service delivery management. Deep understanding of ITIL process
Experience in PostgreSQL
Understanding of R&d domain and landscape, compliance and regulations
Stakeholder management, experience in ticket analysis and resolution, problem management. Ability to suggest process improvements and optimizations
Independent working and good communication skills
Elaine Montes
Industrial & Life Science