【1300～1700万円】Associate Medical Safety Director

【求人No NJB2372519】
メディカルセーフティの リード医師（Safety Physician） として、日本のチームをまとめていただくリーダーポジションです。

【業務内容】
・治験または市販後、安全性に関する医学的アドバイス
・有害事象・副作用入力情報を見て新規・既知の判断や、追加収集情報の依頼
・文献評価のサポートなど医学的アドバイス
・研究措置報告の評価
＊領域としては、メジャーな低分子医薬品よりも抗体医薬・生物製剤が多くを占め、
オンコロジーやオーファン領域のプロジェクトが多いです。
＊グローバルレポートラインで、グローバル組織と連携します。

【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

【必須要件】
日本の医師免許（履歴書に忘れずに記載ください）
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・
日本語力：ビジネスレベル以上、十分にステークホルダーとコミュニケーションが取れるレベル・

【尚可】
CROやメーカーで経験のある先生
（安全性の経験は必須ではない）・企業経験

【Qualifications】
・ Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education Req
・ Three （3） years of clinical practice experience （e.g ・graduate medical training） with two （2） additional years in the ・pharmaceutical or associated industry ・in any role. Or equivalent combination of education training and experience Req
・ Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice
・ Knowledge of clinical trials and pharmaceutical research process
・ Ability to establish and meet priorities deadlines and objectives.
・ Skills in providing consultation and advice on multiple assignments required as well as initiative and flexibility
・ Ability to establish and maintain effective working relationships with coworkers managers and clients