Associate Medical Safety Director

Grade１６０

部署

Safety 部門

日本拠点のMDは現在4名現在増員でもう1名募集中

このポジションは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レポートはグローバルになります

日本語

• 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

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

English
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 products 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

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

勤務地

東京大阪福岡以外も相談可能

働き方フルリモート

雇用形態勤務時間福利厚生休日休暇

雇用形態正社員または契約社員

勤務時間9:00-17:30

フレックス勤務あり

在宅勤務制度あり

福利厚生法定内社会保険制度法定外IQVIA独自制度の両面から充実した福利厚生制度あり

受動喫煙対策あり

休日休暇年次有給休暇夏季休暇病気休暇特別休暇女性特別休暇育児介護休暇看護休暇など

試用期間あり通常６か月

給与待遇

給与当社規定により優遇します

昇給あり

賞与あり

選考プロセス

①書類選考

③部門面接英語面接あり上長はグローバル

状況によって変更人事面談を実施する場合あり

応募に必要な書類

日本語の履歴書職務経歴書英語のResume

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

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