Global Pharmacovigilance Risk Minimization Physician – Therapeutic Dermatology
galderma · Barcelona
Descripcion del puesto
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
Por que reporta esta oferta?
Explorar más
Salarios, guías y búsquedas en España.
Salarios por profesión
Postula en 30 segundos
Ingresa tu email para postular. Se creara una cuenta automaticamente.
Al continuar, aceptas nuestras condiciones de uso.
Ya tienes cuenta? Iniciar sesion
¿Una pregunta sobre esta oferta?
Hágala aquí: recibirá el resumen completo por correo, de inmediato.
Publicado hace 8 horas
Expira en 1 mes
1 vistas · 0 interested
Aumenta tus posibilidades
Sube tu CV: te propondremos las ofertas que coinciden con tu perfil.
Analizando tu CV...
galderma
Barcelona
Ofertas relacionadas
-
China Strategic Market Access Lead
astrazeneca Barcelona -
Global Pricing & Access Lead, Rare Neurology
astrazeneca Barcelona -
Senior Clinical Data Manager II
astrazeneca Barcelona -
Field Nurse - Patient Support Programs
Grupo SOHIN Port-d'Espagne -
Part-Time Hybrid Pharmacist
Medical Innovations Ltd Port of Spain