PV Manager

東京23区 外資系企業 7,000,000¥ - 9,000,000¥ 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

  • US pharmaceutical company, with rich development pipeline in oncology, immunology, neurology, infectious disease, vaccine and areas

職務内容

  • Develop and maintain safety process with stakeholders such as spontaneous report, solicited report, literature cases and foreign cases.

  • Triage & Data entry (Quality Check)

  • Triage of incoming cases to prioritise for daily workflow management

  • Ensure the data accuracy in local safety database.

  • Case evaluation

  • Participate in product risk management (pharmacovigilance plan and risk minimisation activities)

  • Make report to PMDA and HQ (GMS)
  • Local and global SOPs and guidelines, relevant PV Agreements and Relevant Japanese regulations

  • Participate in inspections and audits including interviews and provision of requested data

  • Oversight case receipt compliance and deal with CAPA

  • Propose and implement more efficient process

理想の人材

  • Extensive experience in Drug Safety and /or PV
  • Scientific background in CNS and/or immunology helpful
  • Demonstrated track record in the interpretation and application of international regulations regarding safety reporting
  • Sound knowledge of global policies regarding safety surveillance
  • Thorough understanding of the computerised systems to support this function
  • Strong oral and written communication skills as the individual s from diverse cultural backgrounds
  • Strong interpersonal skills, especially in individual leadership and adaptability
  • Have excellent decision-making skills
  • Detail oriented to aim for 100% compliance
  • Experience in change management and scenario planning
  • Communication with the other functions and senior leadership teams
  • Solid foundation for making quick, sound decisions, based on limited information
  • Ability perform trend analysis identify gaps and implement rick mitigation strategy Self starter
  • Solid experience in interactions with colleagues in Japan as well as other colleagues in PVO, PVF, PVP and global PS and external health-care professionals

条件・待遇

  • Contribute to the safe development of drugs for patients with unmet medical needs across wide variety of TAs
  • Work at an industry leading global pharmaceutical company
  • Excellent work/life balance and flexibility options available
コンタクト
Ed Marsden
求人番号
4197870
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
4197870
企業タイプ