Clinical Safety Manager

GenesisCare

Sydney, , Australia
Clinical safety management
End-to-end safety reporting
Safety database oversight
At GenesisCare we want to hear from people who are as passionate as we are about innovation and working together to drive better life outcomes for patients around the world

Job Summary

  • At GenesisCare we want to hear from people who are as passionate as we are about innovation and working together to drive better life outcomes for patients around the world.
  • This is a critical role where your expertise will directly influence patient safety, regulatory outcomes, and study success.
  • Benefits include meaningful work, flexible working arrangements, award-winning learning and development programs, and a comprehensive wellbeing program.

Matching Summary

At GenesisCare we want to hear from people who are as passionate as we are about innovation and working together to drive better life outcomes for patients around the world.

Skills & Requirements

Must-have

  • clinical safety management
  • end-to-end safety reporting
  • safety database oversight
  • regulatory compliance
  • oncology clinical trials
  • pharmacovigilance regulations knowledge
  • team leadership

Nice-to-have

  • experience with TARA PV
  • line management experience
  • regulatory inspection support
  • collaborative team culture
  • continuous process improvement
  • flexible working arrangements

Key Requirements

  • Tertiary qualifications in science or health discipline
  • Minimum 7 years clinical research or regulatory experience
  • At least 4 years clinical safety or pharmacovigilance experience
  • Experience in CRO, pharmaceutical, or biotech environment
  • Strong knowledge of ICH E2A, E2B, E2F, and ICH-GCP
  • Experience supporting oncology clinical trials

Work Rights

Not specified

Tailored Resume

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