Global Head Of Clinical Safety

Galderma

Barcelona, Spain
Hybrid
Benefit/risk assessment of products
Signal detection and risk management
Aggregate safety reports ownership
As the Global Head of Clinical Safety, you will be responsible for providing medical safety expertise for the benefit/risk assessment of products in clinical development, with a specific focus on our key biologic (Nemolizumab)

Job Summary

  • As the Global Head of Clinical Safety, you will be responsible for providing medical safety expertise for the benefit/risk assessment of products in clinical development, with a specific focus on our key biologic (Nemolizumab).
  • This position is also responsible for the medical review of safety-related information in study protocols, study reports, investigator brochures, product labelling (including CCDS), periodic/aggregate reports, risk management plans and responses to specific questions from health authorities.
  • You will have the opportunity to make a meaningful positive impact on the lives of patients and consumers who suffer from a variety of dermatological conditions and to live the Galderma vision which is 'Advancing dermatology for every skin story'.

Matching Summary

As the Global Head of Clinical Safety, you will be responsible for providing medical safety expertise for the benefit/risk assessment of products in clinical development, with a specific focus on our key biologic (Nemolizumab).

Skills & Requirements

Must-have

  • Benefit/risk assessment of products
  • Signal detection and risk management
  • Aggregate safety reports ownership
  • Development Risk Management Plans
  • Safety data review during clinical trials
  • Line manage pharmacovigilance staff

Nice-to-have

  • Advancing dermatology for every skin story
  • Positive energy and teamwork
  • Personalized career path development
  • Ownership from day one

Key Requirements

  • Doctor of Medicine (M.D.) required
  • 12 years' experience in global clinical safety/pharmacovigilance
  • Minimum 3 to 5 years of line management experience
  • Significant experience with international regulations
  • Knowledge of biologics development regulations
  • Experience with health authority interactions

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter