お仕事情報

お仕事情報

Manager, Global Safety and Pharmacovigilance:SS-3485MY

  • 外資系企業
  • 女性が活躍
  • 管理職・マネジャー
  • 英語を活かす

米国の大手ヘルスケアアウトソーシング企業です

求人コード SS-3485MY
募集職種 Manager, Global Safety and Pharmacovigilance
職務内容 Job Functions
・Direct the operations of the Global Safety and Pharmacovigilance group in a region
・Provide managerial oversight of the Global Safety and Pharmacovigilance Group
・Ensure that inVentiv Health Clinical is in compliance with safety reporting requirements of regulatory authorities
・Ensure that inVentiv Health Clinical meets client expectations and requirements for safety reporting
・Provide regulatory consultation regarding safety reporting for investigational drugs
・Prepare documents describing the process for monitoring and reporting serious adverse experiences (e.g., SOPs, user manuals)
・Maintain proficiency in current knowledge of all applicable regulatory guidelines and regulations relating to safety reporting
・Act as project manager for stand-alone Safety and Pharmacovigilance projects
・Provide input to the overall processes, policies and procedures of the review and processing of safety information in the department
・Coordinate with Medical Affairs, Clinical Research and Data Management for the efficient and timely review of safety information at inVentiv Health Clinical
・Interact with clients and internal staff to provide advice and guidance on safety review issues; provide training and consultation to clients
・Assist Business Development for client development presentations that involve safety reporting as a potential service; provide adequate input into client proposals
・Remain current on global pharmacovigilance requirements and disseminate any relevant changes to affected inVentiv Health Clinical personnel
・Identify training needs in pharmacovigilance and work with Training Group to implement appropriate training
・Advise senior management on adequate budget and resource planning
・May perform database administration functions
応募要件 Minimum Requirements
・Bachelor’s Degree in a life science or nursing
・Seven years of relevant pharmaceutical or clinical research industry experience
・Excellent knowledge of ICH guidelines and regulations relating to pharmacovigilance
・Prior management and supervisory experience
・Demonstrate working knowledge of MS Office applications
・Excellent verbal and written communication skills
・Ability and willingness to travel(~20%)
勤務地 東京
年収 900万円~1300万円
最終学歴 理系大卒
推奨される資格要件 理系
その他

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