Job

JOB

About Pharmacovigilance

Our Pharmacovigilance specialists are responsible for collecting and recording safety information, conducting safety assessments, and generating reports on adverse events/side-effects in patients upon drug administration.
It is critical to promptly and appropriately assess the seriousness of adverse events and causality utilizing medical and pharmaceutical knowledge.

  • Through timely assessment and reporting of drug safety information, Pharmacovigilance staff can contribute to protecting patient safety by promoting the appropriate use of drugs.
  • As Pharmacovigilance staff have access to information on various drugs, they can enrich their medical and pharmaceutical knowledge as they accumulate experience.

Scope of Work Scope of Work

A major objective of Pharmacovigilance is to "manage risks in drugs, etc. and protect patients from side-effects". By promptly collecting, analyzing, evaluating, and reporting on safety information concerning side-effects that could not be confirmed during clinical trials, Pharmacovigilance staff fulfill an extremely important mission of contributing to the safer and more effective use of new drugs and medical devices.

    • Reporting on individual cases of various safety information collected from drugs, medical devices, regenerative medicine-related products, etc. in Japan and overseas
    • Translation
    • Progress management of individual case reporting
    • Processing safety information from literature search
    • Pharmacovigilance-related document preparation work
  • It is necessary to submit safety reports within deadlines.
  • Pharmacovigilance staff also have opportunities to use their English ability because they routinely handle overseas cases.

Skill Required Knowledge and Skills

  • Medical/Pharmaceutical knowledge
  • English ability
  • Logical thinking
  • Communication ability

Skill Knowledge and Skills gained on the job

  • Regulations in Japan, US, EU and other Asian countries related to safety reporting for drugs, medical devices, regenerative medicine products, etc. in Japan and overseas
  • Latest drugs information
  • Multitasking ability

Career Paths Career Path Examples

  • Ms.A

    • Pharmacovigilance (5 years)
    • Project Management (internal transfer)
  • Mr.B

    • Pharmacovigilance (5 years)
    • Pharmacovigilance Project Leader
  • Ms.C

    • Pharmacovigilance (7 years)
    • Quality Management (internal transfer)
  • Mr.D

    • Pharmacovigilance (3 years)
    • Transfer to another subsidiary within CMIC Group

Data Data

  • Academic background

    Science72%

    Humanities28%

  • New graduate to Mid-career Ratio

    New
    graduates
    26%

    Mid-career74%

  • Ratio of men to women

    Men18%

    Women82%

  • Age ratio
    of employees

    20s23%

    30s46%

    40s22%

    50s9%

As of March 31, 2023