Responsible for generating post-marketing safety evidence of products using real-world data in Japan. 企業情報 * Top Global Pharmaceutical Company * Highly specialized in Oncology area with rich pipeline 職務内容 - Creates study report, and Re-examination dossier
* The Safety Management Officer will oversee all safety management and pharmacovigilance (PV) activities in Japan. * This role involves ensuring compliance with local regulations, managing risk, and maintaining high standards of safety for all products.
Program ownership in Japan with final accountability for clear definitions of program goals, plans, decisions and deliverables to meet those goals. Ready to level up to be a leader of Global Clinical Project Management? 企業情報 * Global
Oversee safety and pharmacovigilance in clinical trials, including adverse event analysis, reconciliation, safety reporting, regulatory compliance, stakeholder liaison, and document management. Client Details Leading pharmaceutical innovator driving the forefront of medical discovery through cutting-edge research and development
Leading the local trial team to deliver results compliant with assigned protocols, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory requirements. Actively contributing to process improvement and site management, you will train and
Job Description The Senior Manager / Manager of Clinical Pharmacology in Clinical Pharmacology & Pharmacometrics (CPP) serves as the clinical pharmacology country lead on program, clinical pharmacology, and clinical study teams, providing strategic leadership and expertise in interpretation of clinical pharmacology data for
( 概要 ) 日本国内で治験を実施するためのオペレーションチームリーダーとして,国内外のステークホルダーとの協議•交渉など,エキスパートとしてのコミュニケーションを通じ,品質を確保した臨床試験を計画通りに遂行する。 ( 具体的な業務例 ) •試験実施施設の選定戦略,症例組み入れプラン•戦略の作成及び実行 •試験遂行のための現場の責任者としてモニターへの指示及びモニターへの助言 •試験全体の進捗および GCP , SOP に沿った臨床試験の実施と品質の確保 •国際共同試験の場合,海外担当者からの指示の正確な把握及び協議を含めた円滑なコミュニケーション •試験における Risk & Issue Management •治験契約締結交渉,データ固定, GCP • SOP に基づくモニタリングに対するモニターへのフォロー •チームビルディング,ステークホルダーマネジメントによるチーム作り •社内の改善活動 / Task force team への参加 •試験全体の予算の管理 Position Summary: The
Position Summary: Responsible for the development and analysis of site contracts including but not limited to drafting, negotiating, and finalizing agreements related to clinical trials and/or overseeing a Clinical Research Organization responsible for contract negotiations. The lead will assist
International SOS is the world’s leading medical and security services company with over 12,000 employees working in 1,000 locations in 90 countries. Established 35 years ago, we have become the market leader in global telehealth services
Do you enjoy a role in management? Are you interested in helping to shape a new solution in Japan About our Team Elsevier Health applies innovation, facilitates insights, and helps drive more informed decision-making for our
