Company Description We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North
ベーリンガーインゲルハイム製薬株式会社 勤務地：大崎オフィス（国内出張あり） ＊日本語の応募書類に加え、できれば英語CVもご送付をいただけますと幸いです。 1. CMOにて発生する各種変更(原薬・副原料・機器等)に対して、CMOからのQualification計画を製剤技術の観点からReviewし、実行する。 （工業化検討・PQ/PV計画書/報告書Review, 必要に応じて現場立会い） 同様にCMOと協議し、Process堅牢化・改善を進める。 2. 新製品の中で、ドイツからの完成品輸入品、国内CMO包装品について、立上げ準備を行う。 技術的な立場から日本国内での新製品立ち上げProjectに参画し、ドイツ・国内CMOと協力しながら準備を進める。 3. CMOにて発生する各種変更に伴う、承認書への記載内容変更案のReview 新製品の薬事申請書類のReview Basic purpose of the job* •Prepare for the initial production for the launch of new products (FG import or Japanese CMO packaging) providing
About Johnson & Johnson At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive,
Company Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe,
Senior Specialist, PS Operational Excellence leads implementation of appropriate operation to ensure PV activities in compliance with GVP/GPSP/GCP regulation with collaboration with internal/external partners. The Senior Specialist, PS Operational Excellence is responsible for: o Develop and maintain
国内外の安全性データの監視、評価、規制対応をリードするポジションです。日本のGVP規制に基づく業務経験をお持ちで、医薬品安全性における専門知識とグローバルな視点を活かしたい方に最適なポジションです。 企業情報 希少疾患や特殊な治療ニーズを抱える患者さんのための医薬品を提供するグローバルで展開する製薬企業です。 職務内容 * 国内外の医薬品安全性データのモニタリング、評価、規制対応 * J-RMP、J-PSUR、J-DSUR等の安全性関連資料の作成および提出 * リスクマネジメント * 臨床試験チームでの安全管理計画の準備、データレビュー、科学的議論への参加 * 安全性関連のシステム・プロセスの開発および運用 * ベンダー管理等 理想の人材 * 理系の学位をお持ちの方 * リスクマネジメントのご経験がある方 条件・待遇 * 各種社会保険 * リモート勤務制度 To apply online please click the Apply button below. For
Basic purpose of the job The manager of RRL JP provides strong leadership to develop and implement regulatory strategy for the assigned products/projects as RRL JP, and exercises activities which include: An integral member of the
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
We are Lightsource bp – and we’re on a mission to become a global leader in onshore renewables, anchored by our proven track record in solar development. For over a decade we’ve been actively working to
We are Lightsource bp – and we’re on a mission to become a global leader in onshore renewables, anchored by our proven track record in solar development. For over a decade we’ve been actively working to
Responsible for executing the following basic MSL tasks under the guidance of his/her superior and the support of a senior MSL. • Responsible for building trust relationship with Key Individuals (KIs) in their therapeutic area and
Develop sales revenue/opex budgets, sales and marketing strategies and forecasts for PV system. Implement business strategies and initiatives of sales channel management and consolidation Responsible for the management and execution of assigned projects, including interfacing with other
Job Description Summary・Develop the medical expert engagement plan(s) in assigned therapeutic area(s) and local areas under the direction and agreement of the Group manager. Job Description Develop the medical expert engagement plan(s) in assigned therapeutic area(s)
Basic purpose of the job - Lead/Manage GPSP activities such as planning post marketing surveillance studies as additional PV plan based on safety specification in compliance with GVP and GPSP regulations, lead vendor management, Reexamination and process
Company Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe,
Company Description We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North
Enphase Energy is a global energy technology company and leading provider of solar, battery, and electric vehicle charging products. Founded in 2006, Enphase transformed the solar industry with our revolutionary microinverter technology, which turns sunlight into
Tenstorrent is leading the industry on cutting-edge AI technology, revolutionizing performance expectations, ease of use, and cost efficiency. With AI redefining the computing paradigm, solutions must evolve to unify innovations in software models, compilers, platforms, networking,
Job Overview Provide project related assistance for all assigned project(s), sites and project teams. Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality
Company Description We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North
