大手外資系CROでの Associate Medical Safety Director
- 会社区別外資系大手CRO
- 職種メディカルドクター
- 勤務地フルリモート
- 年収1000-1700万円（スキル・経験による）
資格・要件
【必須要件】
日本の医師免許
企業経験は必須としていないが、リモート環境でも柔軟に対応できる、適応能力は必要です
リーダーシップ、マネジメントスキル
英語力：ビジネスレベル
【尚可】
CROやメーカーでの経験（安全性の経験は必須ではない）
職務内容
Essential Functions
• Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary
• Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements
• Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
• Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile
• Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data
• Represent safety and clinical data review findings during client meetings
• Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports
• Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies
• Provide medical oversight for label development, review and change
• Provide medical support and attendance at Data Safety Monitoring Board Meetings
• Attends and contributes medical safety evaluation on Safety Monitoring Committees
• Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document
• Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments
• Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract• Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture.
• Act as Global Safety Physician or Assistant or Back-up on projects as assigned
• Attend project meetings, medical safety team meetings, and client meetings as requested
• Ensure coverage for all medical safety deliverables within regulatory or contracted timelines
• Provide medical escalation support for medical information projects
• Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects
• 24 hour medical support as required on assigned projects
• Maintain awareness of medical-safety-regulatory industry developments
【その他情報】
契約期間：期間の定めなし
試用期間：6か月
就業時間：9:00～17:30（標準的な勤務時間）
フレックスタイム制：有（フルフレックス）
休憩時間：60分（11:30～13:30）
時間外労働：あり
休日休暇：完全週休２日、夏季、年末年始、慶弔休暇、女性特別休暇、長期勤続休暇、有給休暇
受動喫煙対策：あり 就業場所 全面禁煙
加入保険：雇用・労災・健康・厚生年金保険
在宅勤務制度：有
【将来的に従事する可能性のある職務内容】会社の定める職務
＜将来的に勤務する可能性のある場所＞会社の定める事業拠点（テレワークを行う場所を含む
