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セイフティーフィジシャン（MD）/ノンラインマネージャー or グループマネージャー/ペイシェントセイフティー＆ファーマコビジランス部

年収：応相談

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部署・役職名	セイフティーフィジシャン（MD）/ノンラインマネージャー or グループマネージャー/ペイシェントセイフティー＆ファーマコビジランス部
職種	PV（安全性情報担当）
業種	医薬品メーカー
勤務地	東京都
仕事内容	【Basic purpose of the job】 Based on sound medical knowledge, this role defines the local Patient Safety & Pharmacovigilance (PSPV) strategy not aonly for the delegated asset (AT) but also other products as needed and ensures the consistent implementation of the BI risk mitigation strategy to safeguard patients and / or clinical trial subjects by providing benefit/risk (B/R) expertise to the cross-functional teams based on the framework provided by Global PSPV . Together with the LPSL, the local Patient Safety Physician (PSP) ensures by contributing to the local PSPV strategy and by responsibly taking care of delegated parts of the local PSPV system to establish and maintain a high-quality local PSPV system which is compliant with external regulations and internal processes. 【Accountabilities】 As an expert of benefit/risk (B/R) profile, which are assessed by global BR team and aligned among global and local, engage to take safety assurance measures such as preparation of J-RMP, proper use of drugs and closely work with evidence/asset team by providing B/R knowledge and work with global team by inputting local needs/insight. ・Lead to prepare local Risk management Plans in response to Japanese specific requirements (e.g. country-specific format) and content in liaison with GPV functions. ・Implementation and progress of global risk minimization measures, lead to prepare local RMP development and implementation not only for the delegated asset (AT) but also other products as needed. Provide PV input and insights to local labelling documents and educational materials (e.g. SPC, PIL) in time and quality. ・Perform local safety data monitoring not only for the delegated asset (AT) but also other products as needed. Timely information of the respective PVWG Chairperson on any relevant new safety information received from local sources for BI products or for products of the same class. ・Promote implementation of safety assurance measure such as proper use of drug, including preparation of guidelines for them in collaboration with stakeholders (e.g.LRA, legal &complaince) ・Perform Medical Quality Review of all fatal / life-threatening cases as needed and defines appropriate follow-up measures. Complete ‘fatal case investigation’ report as needed. Manage health authority requests, potential safety issues and / or crisis management not only for the delegated asset (AT) but also other products as needed and together with global/local stakeholders. Contribute to the PSPV Culture, Local PSPV Strategy & the establishment and maintenance of a high-quality local PSPV system, Review controlled documents (e.g. PV Working Instruction, PV Repository, applicable sections in PSMF annexes, local SOPs, etc.) also contribute to Japan initiatives to promote Patient Safety & Pharmacovigilance concepts and conduct PV trainings, where the training needs were identified, for internal and external customers. To be ready for inspection and support to management of non-compliance ・Reporting of non-compliances as soon as becomes aware of the issue and Contribute to investigate non-compliances and associated CAPA (Corrective and Preventive Actions) activities. Take over CAPA Lead Function, if required. ・Establish and support local inspection readiness, participate in PV audits and PV/GPSP/GCP inspections. Support the implementation activities to enhance PV compliance culture and PV awareness at local level of the organization in line with global recommendations Proactively cooperation with Global PSPV on any upcoming new regulations or BI processes to assess the local impact and their implementation within the team. ・Contribute to seting up/optimizing of local PSPV processes including the takeover of subtasks e.g. creation/revision of the related documentation (Standard Operating Procedures (SOPs), Local PV System Framework, KMed Assets, etc.) 【Regulatory and / or Organisational Requirements】 Excellent knowledge of applicable global, regional and local PV regulations, BI processes and relevant GxP requirements. Be compliant and acts within ethics at all times. 【Job Complexity】 The position requires extensive regulatory,scientific knowledge and balanced risk-based decision making. This needs to take into account needs and requirements of other functions, departments and units. 【Interfaces】 Local Medical Director, Global Patient Safety & Pharmacovigilance, MSG,CDMAs, LRA, MKT, SL, RWD 【Job Impact】 Conduct and Establish internal/external collaborations by sharing best practices 【Our Company】 Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. 【Why Boehringer Ingelheim?】 With us, you can develop your own path in a company with a culture that knows our differences are our strengths – and break new ground in the drive to make millions of lives better. Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed. Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after – as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you’ll be helping to transform lives for generations.
応募資格	【必須（MUST）】＜Minimum Education/Degree Requirements＞ Medical doctor Experience as clinician ＜Job Expertise＞・1+years’ experience at Experience at pharmaceutical industry at medicine department ・Experience in the field of clinical development is highly preferable ＜Knowledge and experience＞・Substantial knowledge about local GVP/GPSP regulation and global GVP regulation. ・Knowledge and experience of preparation of periodic report/RMP/EPPV ・Knowledge and experience of performing signal monitoring ・Knowledge and experience of PJ management ・Experience on industry activities (e.g. participating working group across companies) (preferable) ・Excellent command of English language (toeic score more than 785) Skill and Competencies ・Proactive and assertive attitude to establish team and networking ・Problem solving skill and crisis-management skills ・Analytical skills on industrial trend. ・Conceptual and strategic thinking ・Project management and decision-making skills ・Ability to mentor, coach and train others ・Proactive and assertive attitude with customer service orientation ・Excellent communication and presentation skills ＜Language skills＞ • Japanese: Native • English: Fluent Required English speaking CEFR level : B2
リモートワーク	不可
受動喫煙対策	その他「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」などの場合がその他となります。面接時に詳しい内容をご確認ください
更新日	2026/03/10
求人番号	6176192

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