Jobs list of Pharmaceutical
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Job number: JN -082025-192690 Posted: 2025-09-08
PV職
製薬に関わるコンサルティング経験やプロジェクト・イネーブルメントもしくはプロジェクトマネジメント業務を経験が活かせます。11 - 15 million yen Tokyo Pharmaceutical Pharmacovigilance
- 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
- グローバルPV企画・管理業務
安全管理業務に関わるBusiness Excellence/プロジェクトの戦略的な計画立案・推進支援
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -092025-193492 Posted: 2025-09-03
バイオロジー部副部長候補
大学院 博士後期課程修了(ドクター)卒の方必見です9 - 12 million yen Kanagawa Pharmaceutical Research & Development
- Company overview
- Our Client is engaged in the research and development of RNA-targeted small-molecule drugs.
- Responsibilities
- RNAを標的とした低分子医薬品の創薬研究（医学・薬理学・生物学・生化学が中心）新規創薬標的の探索・提案
ヒット／リード化合物の価値最大化（メカニズム分析・PoC／PoM／PoP検証など）
化合物スクリーニング
年度研究計画策定、実行
マネジメント（正社員・派遣社員）
担当役員への報告・連絡・相談
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -072024-38609 Posted: 2025-09-02
品質保証
大手外資系ファーマでの次世代ポテンシャル採用6 - 9.5 million yen Hyogo Pharmaceutical Quality Assurance / Quality Control
- 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
- Overall Job Purpose:
西神製造所における医薬品／医療機器製造工程、製品試験に関する製品品質保証業務
Job Responsibilities:
新製品導入に伴うGMP対応、品質保証システムの構築、社内関係部門との調整（社内の国内、海外関連部門と協働し、GQP, GMPに基づく製造所としての品質基準、保証システムを構築）
国内販売製品の製造所としての品質管理（製造および試験記録照査、逸脱、変更、バリデーション管理）
品質情報及び品質不良等としての調査、報告業務
製造所における監査対応業務、出荷判定業務
社内の海外製造所との品質改善活動
Yui Osone
Industrial & Life Science -
Job number: JN -092025-193371 Posted: 2025-09-01
主任研究員
顧客/代理店/技術スタッフとプロジェクトの調整を行うことができる方必見です5.4 - 7.2 million yen Aichi Pharmaceutical Research & Development
- Company overview
- Our client is a university-based venture company.
- Responsibilities
- 業務内容:
シングルセルテクノロジーと無細胞タンパク質合成系を組み合わせた独自技術を用いた、モノクローナル抗体探索の受託事業における、実験実務、プロジェクト管理・顧客対応、技術営業をお任せします。また閑散期には社内プロジェクトの研究開発にも携わります。業務詳細:
割合としては実験実務がメインで5～6割程度、プロジェクト管理・顧客対応が2割程度、技術営業が2割程度です。技術営業では、同社への委託を検討中の顧客に対しての詳細な技術説明や、具体的な案件に関して技術面での協議を進めます。
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -072024-33887 Posted: 2025-09-01
Clinical Research Associate/臨床開発モニター(東京・大阪・神戸・在宅可)
Work on global projects at major CRO5 - 10 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- We are a global leader in biopharmaceutical development based in the United States.
Our client is a CRO giant, offering a wide range of services supporting clinical trials at every and all stages. They also provide specialized services for biotech-related clinical trials, leveraging their unique technology and industry expertise.
Our services span the entire spectrum of clinical development, from planning and execution to monitoring and data management. Additionally, we offer advice on pharmaceutical regulation and market deployment, supporting clients through the process from drug approval to market entry. - Responsibilities
- 具体的には以下のような業務を遂行します。
治験を実施する医療機関や医師の選定
治験の依頼・契約
治験薬の搬入及び回収
モニタリング ・GCP(Good Clinical Practice)、治験実施計画書、SOP(Standard Operating Procedure)に則って治験が進んでいるかを確認
直接閲覧（SDV: Source Data Verification)を実施し、症例報告書（CRF: Case Report Form)とカルテ等が一致しているかを照合し、回収
IRB (Institutional Review Board)への文書提出及び手続き
医療機関における保管必須文書が適切に保管されているか確認
モニタリング報告書作成
治験の終了手続き など
Specifically, we will carry out the following tasks:
Selection of medical institutions and doctors to conduct clinical trials
Making requests and handling contracts
Delivery and collection of investigational drugs
Monitoring - Confirming whether the clinical trial is progressing in accordance with GCP (Good Clinical Practice), clinical trial implementation protocol, and SOP (Standard Operating Procedure).
Performing direct viewing (SDV: Source Data Verification), checking whether the case report form (CRF) matches medical records
Document submission and procedures to IRB (Institutional Review Board)
Confirming whether documents required to be kept at medical institutions are stored appropriately.
Monitoring report creation
Clinical trial termination procedures
Yui Osone
Industrial & Life Science -
Job number: JN -072024-143282 Posted: 2025-08-29
[Osaka or Tokyo] Clinical Team Manager
Strong Global Foot Print and High Salary9 - 15 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- Our client is the Japanese subsidiary of a European CRO with over 100 offices and tens of thousands of employees worldwide.
We have a strong business foundation providing global drug development services and a vision to be a “Global Healthcare Intelligence Partner”. We aim to provide advanced drug development operations by combining our experience in drug development with technology that enables 100% virtual clinical trials.
As a partner to pharmaceutical manufacturers and bio-venture companies, we provide a wide range of support from clinical trials to regulatory filings and post-marketing activities. We can also provide a comprehensive range of services including regulatory affairs, pharmacovigilance, and medical writing.
We have a culture where employees work healthy and enjoy challenges, and have been awarded “World\'s Best Company” multiple times by Forbes, an American economic magazine. - Responsibilities
- BUILD RELATIONSHIPS WITH CLIENTS AND LEAD
PROJECTS BY COLLABORATING WITH PROJECT MANAGER (GLOBAL PM OR REGIONAL / LOCAL PM) AND OTHER DEPARTMENTS (INCLUDING PARTNER VENDORS) AS NEEDED -CRA FOR EACH PROJECT, IN-HOUSE CRA, PROJECT LEADS SUCH AS CONTRACTS ASSOCIATE AND START-UP LEAD
MANAGEMENT OF QUALITY, TIMELINE, AND BUDGET IN MONITORING
PROACTIVE RISK MANAGEMENT
CONTRIBUTING TO GROWTH WITH APPROPRIATE GUIDANCE TO INEXPERIENCED MEMBERS
Patrick Chang
Industrial & Life Science -
Job number: JN -082025-193322 Posted: 2025-08-29
開発企画部
医薬品業界でのご経験の方必見です5 - 7 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- Our client primarily manufactures and sells prescription pharmaceuticals and in-vitro diagnostic reagents.
- Responsibilities
- CMC担当者として、同社製品の開発に関するCMC戦略の立案及び承認申請業務を担っていただきます。製造及び試験手順の理解に基づくCTD作成（主にCMC）、及び紹介対応
海外の関係会社/研究機関との協業における資料提出期限や品質の確保
海外の関係会社/研究機関とのコミュニケーション（医薬品の海外導出）
DMFの作成、変更対応
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -082025-193087 Posted: 2025-08-25
CMC薬事担当
バイオ医薬品・ワクチンのグローバル申請・承認取得・変更申請に従事したご経験をお持ちの方必見です6 - 10 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
- 医薬品の開発段階から承認取得、さらに市販後変更管理に渡る関するグローバルCMC薬事戦略の立案と日本・アジア・太平洋地域におけるCMC薬事業務の推進、資料作成、当局対応、等の業務全般を担当する（実際に担当いただく業務は、採用決定後に配属グループ内で調整し決定される）。 実務のリーダー的役割を担い担当業務を推し進める。複雑な課題に対して専門知識を活かして自律的に解決方法を検討し、実務経験や前例も考慮した判断を行う。複雑な情報を明確に説明し、困難な状況でも合意形成を図りながら、与えられた裁量を最大限に活用し、チームの成果を最大化する。 社内業務プロセスの改善点を特定・提案しながら問題解決や効率化を図る。業務を通じて高い組織成果の創出と後進の育成に貢献し、プロフェッショナルとしての自らの成長を組織の成長に活かす。
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -082025-193078 Posted: 2025-08-25
国内外製造所管理
グローバル品目の品質保証及び国内品質保証(GQP)の経験をお持ちの方必見です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
- 上市済みADC製品の品質マネージメントの推進ADC製品にかかわる、国内外の製造所のCMO管理（CMOにおける変更管理、逸脱等の品質課題対応、品質契約締結等の業務）を行い、品質確保を推進する。各CMOの状況に応じ、CMOの品質向上に向けた改善サポートを実施する。また、各国への申請に対し、製造所に対する各国当局からのGMP査察対応をサポートする。
Martin Tsvetkov
Industrial & Life Science -
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 -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 -082025-192639 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 -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 -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 -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