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Global Pharmacovigilance Risk Minimization Physician – Therapeutic Dermatology

galderma · Barcelona

New
Hybrid Senior 🇬🇧 English
Pharmacovigilance Quality Management System (QMS) CAPA management Benefit-risk assessment Signal detection

Job description

About the role

Galderma is opening a new Global Capability Center in Barcelona and is looking for a Global Pharmacovigilance Risk Minimization Physician to join its Therapeutic Dermatology (TD) team. The role leads post-marketing safety activities for approved TD products, with a primary focus on Nemluvio (nemolizumab) and additional TD products, ensuring continuous benefit-risk assessment, regulatory compliance and safe use of treatments worldwide.

Key responsibilities

  • Lead ongoing benefit-risk assessments and identify, evaluate and manage safety risks for assigned TD products
  • Provide medical expertise for post-marketing safety, lead signal detection, validation, evaluation and escalation of individual case safety reports and aggregate data, and develop and maintain Risk Management Plans (RMPs)
  • Ensure compliance with global pharmacovigilance regulations, prepare for regulatory inspections and act as a subject matter expert during audits
  • Support CAPA management and contribute to a robust Pharmacovigilance Quality Management System (QMS)
  • Act as a medical and scientific partner with Clinical Development, Medical Affairs, Regulatory Affairs, Quality, Commercial and other global stakeholders, and represent Global Pharmacovigilance in safety committees and working groups
  • Communicate complex safety concepts clearly and challenge stakeholders to protect patient safety
  • Identify improvements to PV processes, support automation and process optimization, and promote a proactive safety culture

Required profile

  • Medical degree (MD or equivalent) required
  • Minimum 10 years of experience in the pharmaceutical industry, with significant global pharmacovigilance and post-marketing safety experience
  • Experience supporting regulatory inspections, QMS and CAPA management
  • Proven experience in a global environment; dermatology, immunology or other specialty experience highly desirable
  • Fluent English

Required skills

  • Signal detection, safety surveillance, risk management and benefit-risk assessment
  • Knowledge of global pharmacovigilance regulations and compliance
  • Understanding of biologics safety monitoring
  • Strong communication, negotiation and stakeholder management skills

What we offer

  • Hybrid working model
  • Professional development opportunities
  • Exposure to global and cross-functional projects and access to global career opportunities

Questions fréquentes

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Source : ats:workday

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Published 10 hours ago

Expires 1 month from now

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galderma

Barcelona