Pharmacovigilance Manager

東京23区 外資系企業 7,500,000¥ - 11,000,000¥ 外資系企業
  • Manage Patient Safety Activities in Clinical and PMS Programs
  • Keep Compliance with ICSRs Submission in Line with Global and PMDA Regulations

企業情報

  • Top 5 global pharmaceutical company within the speciality medicine, generic and biosimilars area

職務内容

  • Overall pharmacovigilance duties

  • Management and supervision of subcontractors (collection of drug safety information from domestic and overseas sources, literature, academic societies, etc., and management of reports, etc.)

  • Provision of safety information to medical institutions (education and management of preparation and revision of materials)

  • Self-inspection

  • In-house education

  • Creation, revision and management of SOPs

  • Audit response

  • Communication with Global

  • Coordination with domestic partners (succession, AE exchange, etc.)

  • Response to reexamination (PMDA inspection response)

  • Preparation and revision of new RMP

  • Preparation of new and revised RMPs

  • Responses to annual reports such as periodic safety reports and periodic reports on unknown and non-serious adverse drug reactions

  • Coordination with relevant internal departments (post-marketing surveillance, defect information with the Quality Control Department, preparation and revision of package inserts (precautions for use) with the Pharmaceutical Affairs Department, coordination with the Clinical Development Department)
    (post-marketing surveillance, defect information with the Quality Control Department, work related to the package inserts (precautions for use) with the Pharmaceutical Affairs Department, preparation and revision of application materials for development products (preparation and confirmation of the safety part) with the Clinical Development Department)

理想の人材

  • At least 5 years of experience in the pharmaceutical industry (including CRO)
  • 3+ years of experience in PV, regulatory affairs, development, etc. (including evaluation experience)
  • Experience in team/project management
  • PC operation skills
  • English proficiency
  • Experience with databases (ARGUS, ARIS, etc.)
  • GVP knowledge
  • Experience in vendor management
  • Ability to think positively.
  • Good communication skills (internal and external stakeholders)
  • Good communication skills (both internal and external stakeholders)
  • Able to take on new challenges and tackle change

条件・待遇

  • Contribute to the safe development of drugs for patients with unmet medical needs in immunology/CNS areas
  • Work in global clinical trials as part of Japan and East Asian Hub
  • Support growing organisation in Japan
コンタクト
Ed Marsden
求人番号
4182920
電話
+813 6832 8981

求人情報

勤務地
雇用形態
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
4182920
企業タイプ