Senior PV Specialist

大阪市 外資系企業 外資系企業
  • Develop Innovative New Drugs at a Leading Global Contract Research Organization
  • Contribute the Safety and Wellness of Patients Globally

企業情報

  • Leading US based bioscience solutions business with extensive clinical trial capabilities in Oncology, Rare Disease and CNS.

職務内容

  • Proactively providing case processing activities as requested to ensure high-quality individual case safety reports of adverse events
  • Provide accurate individual case reports for submission to regulatory authorities, sponsors and and participating clinical trial investigators in compliance with regulatory requirements and time frames for reporting.
  • Serve as a member of project teams. Communicate timelines, delivering quality and timely input to meet the needs of the project team and informs the project team on the status of activities and issues.
  • Maintain awareness of changes to regulatory guidance documents, requirements and state-or-the-art pharmacovigilance processes
  • Revises and maintains processes and procedures for drug safety in compliance with regulatory requirements and company standards.
  • Support Pharmacovigilance Audits and Inspections as needed concerning the Global Case Management function.
  • Any other activity that may reasonably be required.

理想の人材



  • Hands-on experience in pharmacovigilance case processing (data entry, triage, evaluation, QC, submission).


  • Japanese language proficiency of business level


  • Ability to prioritize, time line management


  • Ability to read and write short sentences using English dictionaries


  • Associate degree or higher


  • Nice to have: any leadership experience in pharmacovigilance. (e.g. OJT, SOP renewal, system update, managing timeline and quality)


  • Nice to have: English proficiency: TOEIC 600 or equivalent


  • Nice to have: Ability to make good relationship with stakeholders, leadership


  • Nice to have: Medical background (Medicine, Pharmacy, Medical Technology, Nursing, etc)

条件・待遇

  • Opportunity to build leadership skills and move into a management position
  • Opportunity to work on a large number of diverse projects to develop a broad range of IMPs
  • Work on global studies at an industry leading international company
コンタクト
Ed Marsden
求人番号
JN-092023-6179204
電話
+813 6832 8981

求人情報

分野
ライフサイエンス
職種
製薬
業界
ヘルスケア・製薬
勤務地
大阪市
雇用形態
正社員
担当コンサルタント
Ed Marsden
担当コンサルタントの電話番号
+813 6832 8981
求人番号
JN-092023-6179204
企業タイプ
外資系企業

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