[Hiring] Associate Medical Safety Director @IQVIA

Role Description

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。

• 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

• 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

Qualifications

• Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education
• 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
• 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

Requirements

• 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

Benefits

• 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：当社規定により優遇します
• 昇給：あり
• 賞与：あり

Company Description

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 https://jobs.iqvia.com