Pharmacovigilance Reporting Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape
Responsible for leading the team and encouraging changes and challenges, influencing stakeholders inside and outside the company, contributing to the achievement of organizational goals, enhancing performance and productivity, and fostering talent development regardless of whether there
部門：安全性部門 Product Specialist メインの業務内容： 顧客から新規案件についてRFP ( Request for Proposal ) を受領したら、見積書と提案書を作成する役割。 その他状況により、PM的な役割も担っていただく。 必須経験：PV経験5年以上 、英語スキル （英語面接が最終面接） Job Overview Accountable for management and service delivery excellence of a range of large sized regional and global projects as assigned,
Basic purpose of the job* The Head of Development Regulatory Affairs 1 or 2 has responsibility to develop and implement regulatory strategy for the assigned therapeutic areas (TAs) and exercises activities which include: Guide subordinates on
Basic purpose of the job Independently writes and manages clinical documents, such as clinical trial reports, Investigation Brochures, Protocols and briefing documents, in both local and global cross-functional project- and study teams, as well as local
Basic purpose of the job To contribute to execute CDMA (Clinical Development & Medical Affairs) activities in Japan according to TA (Therapeutic Area) strategy between start of preclinical development and late stages of commercialization. Accountabilities ・Strengthen
Basic purpose of the job To contribute to execute CDMA (Clinical Development & Medical Affairs) activities in Japan according to TA (Therapeutic Area) strategy between start of preclinical development and late stages of commercialization. Accountabilities ・Strengthen
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
About our client: Our client brings together Pharmacovigilance expertise, Third party system knowledge and Deep technology to develop well-defined solutions, which address challenges across Medical Affairs, Regulatory and Safety functions. Our client solutions free up responsible personnel
Job Opportunity: Pharmacovigilance Project Manager - Japan, Tokyo About Our Client Our client is a world-leading healthcare intelligence and clinical research organization. Proudly fostering an inclusive environment that drives innovation and excellence, the organization welcomes you to
Job Opportunity: Pharmacovigilance Associate - Japan, Osaka About Our Client Our client is a world-leading healthcare intelligence and clinical research organization. They are proud to foster an inclusive environment that drives innovation and excellence, and they welcome
Basic purpose of the job Manage case processing activities for NBI’s investigational and marketed products including case submission to GPV and PMDA according to BI’s internal procedure and local regulation. Conduct safety risk management activities for
Basic purpose of the job Manage case processing activities for NBI’s investigational and marketed products including case submission to GPV and PMDA according to BI’s internal procedure and local regulation. Conduct safety risk management activities for
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
Pharmacovigilance System • Implement and maintain a pharmacovigilance system for the UCB products authorized in the territory and ensure compliance with applicable regulatory and company requirements; • Work in close collaboration with corporate Patient Safety teams to ensure
職務内容： 医薬品の安全性に関するリスクを管理し、以下のPV活動を通じて、製品のベネフィット/リスクバランスの最適化に貢献します。 ・安全性データの正確かつ迅速な分析に基づく予防的な安全対策の実施 ・社内外のステークホルダーとの協働による医薬品リスク管理の実施 ・重要な安全性シグナルのタイムリーな検出および評価 ・製品の安全性検討事項に基づく、規制当局およびグローバルPVとの緊密なコミュニケーション ・ 必要なリスク最小化活動の計画と実行をプロアクティブに行う ・ 臨床開発段階から市販後まで、エビデンスに基づく質の高い安全性分析と評価を一貫して行う 主な業務内容： ・J-RMP（医薬品リスク管理計画書）の作成、改訂 ・リスク最小化策の計画・実施・評価（医療関係者向け資材、患者向け資材、情報提供等） ・EPPVの計画、管理、規制当局への報告 ・文献・海外措置情報の評価、規制当局への報告 ・安全確保措置の立案（使用上の注意改訂の立案、等） ・安全確保措置実施の計画・管理・報告書作成（情報提供等） ・規制当局とのコミュニケーション(照会事項対応) 必要なスキル： ・ 医薬品に関する科学的知識およびデータ分析スキル ・ プロジェクトマネジメント/タスク管理スキル ・ 英語でのコミュニケーション能力 ・ 規制要件を含むファーマコビジランス活動に関する知識 Job summary： Manage safety risks and contribute to optimizing
Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines
Key Accountabilities Country Quality System management Lead the implementation and maintenance of GxP quality system with respective operation units, the continues quality system implementation for competencies and related Quality documentation of GxP area: medical, pharmacovigilance, regulatory and
Basic purpose of the job To contribute to execute CDMA (Clinical Development & Medical Affairs) activities in Japan according to TA (Therapeutic Area) strategy between start of preclinical development and late stages of commercialization. Accountabilities ・Strengthen
Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, youll be part of
