International Pharmacovigilance (pv) Senior Manager - Apac

Vertex Pharmaceuticals

Hybrid
Excellent english and chinese communication skills
China pv experience required
Strong understanding of china gvp regulations
This role ensures all pharmacovigilance activities comply with global and local regulatory requirements throughout the APAC region with a specific emphasis on China

Job Summary

  • This role ensures all pharmacovigilance activities comply with global and local regulatory requirements throughout the APAC region with a specific emphasis on China.
  • The incumbent will lead the development of Standard Operating Procedures and provide oversight of PV activities performed under delegated models.
  • Candidates must possess excellent written and oral communication skills in both English and Chinese to effectively interface with local health authorities.

Matching Summary

This role ensures all pharmacovigilance activities comply with global and local regulatory requirements throughout the APAC region with a specific emphasis on China.

Skills & Requirements

Must-have

  • Excellent English and Chinese communication skills
  • China PV experience required
  • Strong understanding of China GVP regulations
  • Experience with local PV representatives in China
  • Ability to lead SOP development for PV systems

Nice-to-have

  • Expert-level knowledge of NMPA expectations
  • Experience managing delegated PV models
  • Ability to conduct safety issue presentations
  • Track record of inspection defense preparation

Key Requirements

  • 7-8 years pharmaceutical drug safety experience
  • B.S. degree or Advanced degree (PharmD, M.S.N)
  • Specific China PV experience mandatory
  • Remote-Eligible work arrangement available

Work Rights

Not specified

Tailored Resume

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