企業概要 We are PrimeVigilance (part of Ergomed Group), 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, North
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
Primary Purpose / Regulatory Responsibilities: Collaborate with the Process Management Team members and the Product Management Team members to ensure Safety communication and product stewardship • Ensure Pharmacovigilance systems, operations and procedures are in place within the
医薬品の安全性評価を担うメディカルポジションとして、グローバルチームをリードしながら安全性戦略の策定・実行を担います。開発から市販後まで一貫して関与し、医学的視点から重要な意思決定に関わる役割です。 企業情報 国内外で医薬品の研究開発・製造・販売を展開する大手製薬企業。グローバル連携を重視した組織体制を持ち、革新的な医療価値の創出と患者中心の取り組みを推進しています。働きやすさや中長期的なキャリア形成にも力を入れている企業です。 職務内容 * 医薬品の安全性評価におけるグローバルチームのリード * 開発および申請に向けた安全性戦略・リスクマネジメントの策定 * シグナル検出や安全性文書、各種報告書への医学的インプット提供 * Benefit-Risk評価および安全性データの統合的レビュー * 社内外会議におけるPV代表としての対応 * 規制要件の理解・社内トレーニングの実施 * クロスファンクショナルチームと連携しプロジェクト推進 理想の人材 * 医学部卒（MD）および臨床経験を有する方 * 製薬業界における業務経験 * ファーマコヴィジランスまたは安全性関連業務の経験（尚可） * 日本語ネイティブレベル * 英語での業務対応力（文書レビュー、会議、プレゼン等） 条件・待遇 * 各種社会保険 * 在宅勤務制度 * フレックスタイム制度
Company Description Sirtex Medical is a global leader in healthcare, with offices in the U.S., Australia, Germany, and Singapore, dedicated to improving patient outcomes. Our mission is to be at the forefront of minimally invasive cancer
CRA II Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate
Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring
About Eucalyptus We’re on a mission to make good health last a lifetime. More than 1 billion people live with obesity worldwide, driving preventable chronic conditions. We’re here to build better long-term care. Euc is the
The GCDSE provides clinical and R&D expertise, guidance and direction in the context of the region/country, in which they operate. As the leader of the Clinical (or Extended Clinical) Team, the GCDSE is the clinical representative
Company Description Sirtex Medical is a global leader in healthcare, with offices in the U.S., Australia, Germany, and Singapore, dedicated to improving patient outcomes. Our mission is to be at the forefront of minimally invasive cancer and
企業概要 We are PrimeVigilance (part of Ergomed Group), 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, North
Company Description Sirtex Medical is a global leader in healthcare, with offices in the U.S., Australia, Germany, and Singapore, dedicated to improving patient outcomes. Our mission is to be at the forefront of minimally invasive cancer and
Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring
企業概要 About AbbVie AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples
Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring