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RAPV Specialist

RAPV Specialist

Pierre Fabre GroupTaiwan, Taipei
26 days ago
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 employees.
  • Assess the HSE compliance with the group's requirement that constitute the safety basics for our activities.

    • Dermo-cosmetic Support for Export Market

  • Fulfil Dermo-cosmetic distributors’ needs for PIF and scientific dossier inquiries.
  • Regularly monitor the latest regulatory change for cosmetic industry.
  • To monitor of cosmetic advertisement compliance for both own brands and competitors.
  • Parallel export / import tracking.

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    Specialist • Taiwan, Taipei