(sr) Safety Scientist/associate Safety Director

Roche UK

Beijing, China
Not specified; not specified; not specified
Fully remote
Formal medical qualifications md or equivalent
Post-graduate clinical practice experience
Icsr case management and medical review
The role involves developing and maintaining an expert understanding of the safety profile of assigned products while collaborating with Portfolio Clinical Safety colleagues

Job Summary

  • The role involves developing and maintaining an expert understanding of the safety profile of assigned products while collaborating with Portfolio Clinical Safety colleagues.
  • Candidates are responsible for individual and aggregate case reporting activities including ICSR case management and aggregate reporting such as DSUR and PBRER.
  • Roche fosters a culture of personal expression and open dialogue where every voice matters to prevent, stop, and cure diseases globally.

Matching Summary

The role involves developing and maintaining an expert understanding of the safety profile of assigned products while collaborating with Portfolio Clinical Safety colleagues.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • Formal medical qualifications MD or equivalent
  • Post-graduate clinical practice experience
  • ICSR case management and medical review
  • Aggregate reporting DSUR PBRER preparation
  • Signal detection and STAR maintenance
  • Risk management plan RMP development
  • Regulatory submission support IND NDA MAA

Nice-to-have

  • Board certification in relevant clinical specialty
  • Fluency in Mandarin and English languages
  • Experience with global remote team collaboration
  • Strong presentation and communication skills
  • Ability to mentor junior scientists
  • Project management methodology application
  • Process improvement orientation

Key Requirements

  • MD MB BS or MB ChB degree required
  • 4+ years clinical drug development experience preferred
  • 2+ years clinical drug safety role experience preferred
  • GxP and regulated process knowledge required
  • Mandarin and English fluency preferred

Work Rights

Not specified

Tailored Resume

Cover Letter