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PMS manager

managerial role

FunctionPharmacovigilance
Salary ¥‎8 - 11m
Date2022-06-28
IndustryPharmaceutical
LocationTokyo
Ref.#Job-00222193

CLIENT OVERVIEW:

Our Client is a bio pharmaceutical company.

RESPONSIBILITIES:

  • Planning, management and implementation of post-marketing surveillances and studies.
  • Preparing for Japanese periodical safety reports (J PSUR) and submission
  • Preparing for re examination application dossier, submission and inspection
  • Preparing for re evaluation application dossier, submission and inspection
  • Implementation of PMS operations based on entrustment contract
  • REQUIREMENTS:

    Education:

    • Bachelor’s degree of science or equivalent
    • Pharmacist is preferable
    Experience:
    • Experience of PMS activities under GPSP and/or GCP and/or GVP; 3 years or more experience of PMS is preferable.
    Competencies:
    • Broad knowledge of GPSP/GCP/GVP, related laws and regulations in Japan.
    • Proficiency in written and spoken Japanese.
    • Good communication skills in English.
    • Good communication and management skills both internally and externally.
    • Problem solving / logical thinking.


    BRS Consultant

    Emely Motol

    Pharma

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