安全管理責任者- Safety Control Manager/pharmacovigilance

Krystal Biotech

Tokyo, Japan
On-site
Japanese pharmacovigilance regulations
Pmda compliance expertise
Adverse event reporting management
The role ensures the maintenance and continuous enhancement of the pharmacovigilance system while fulfilling Marketing Authorization Holder duties

Job Summary

  • The role ensures the maintenance and continuous enhancement of the pharmacovigilance system while fulfilling Marketing Authorization Holder duties.
  • Candidates must possess a strong understanding of Japanese pharmacovigilance regulations, including those of the PMDA, to ensure local compliance.
  • The position requires overseeing safety data analysis, managing risk assessments, and preparing for regulatory inspections and audits.

Matching Summary

The role ensures the maintenance and continuous enhancement of the pharmacovigilance system while fulfilling Marketing Authorization Holder duties.

Skills & Requirements

Must-have

  • Japanese pharmacovigilance regulations
  • PMDA compliance expertise
  • Adverse event reporting management
  • Risk management plan development
  • Regulatory inspection preparation

Nice-to-have

  • Advanced degree in pharmacovigilance
  • Strong analytical skills for safety data
  • Fluent bilingual communication in Japanese and English
  • Experience with CMC safety considerations
  • Collaborative cross-functional teamwork

Key Requirements

  • Bachelor's degree in Pharmacy, Medicine, or Life Sciences
  • Minimum 3 years of pharmacovigilance experience
  • Fluency in Japanese and English
  • Knowledge of PMDA guidelines

Work Rights

Not specified

Tailored Resume

Cover Letter