Job Description

Your mission

Regulatory Affairs:

  • Maintain lifecycle for existing products, including license renew, PMF renew, post-marketing variations, etc.
  • Support product license registration and PMF registration.
  • Contribute to the discussion of registration plan with both local and global stakeholders.
  • Monitor Regulatory regulations and communicate relevant updates to related stakeholders.

    • Pharmacovigilance

  • Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for medical care products.
  • Perform local literature search and report the identified adverse event.
  • Manage submission/distribution of safety reports/updates to Local Health Authorities.

    • Health Safety Environment (HSE)

  • Support in maintaining comprehensive HSE management systems, including identifying hazards and implement controls to mitigate risks.
  • Coordinate the HSE training programs to emp...

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