21 ago
|
Novartis
|
Barcelona
21 ago
Novartis
Barcelona
Experteer Overview
La descripción completa del puesto cubre todas las habilidades asociadas, la experiencia previa y cualquier cualificación que se espera que tengan los solicitantes.
In this Global Program Safety Lead role, you own the end-to-end safety strategy for priority CRM programs, guiding data-informed decisions across development and lifecycle. You will lead safety governance with cross-functional teams and liaise with health authorities to ensure benefit-risk is understood and acted on. You’ll shape safety positioning for regulatory submissions and drive proactive risk management. The role combines scientific leadership with global collaboration to translate safety insight into action at scale. This is a mission-driven opportunity to impact patient safety and medicine development.
Compensaciones / Beneficios
• Lead end-to-end safety strategy for assigned CRM programs across development and lifecycle
• Serve as scientific safety lead within general program, clinical, and trial teams
• Proactively identify, assess, and manage safety signals from all relevant sources
• Chair and drive Safety Management Teams to ensure timely safety decisions
• Own and deliver core medical safety documents with scientific rigor
• Guide benefit-risk evaluations and safety positioning for regulatory submissions
• Act as primary safety contact for health authority interactions and inquiries
• Partner cross-functionally to embed safety insights into development, labeling, and lifecycle decisions
• Ensure compliant documentation, tracking, and governance of all safety activities
• Mentor colleagues to strengthen medical safety capabilities across the organization
Responsabilidades
• Medical Degree or equivalent (preferred)
• 5+ years' experience in pharmaceutical drug development within a global organization
• 3+ years of postdoctoral, patient-facing clinical experience
• 2+ years of hands-on experience in drug safety/pharmacovigilance xqbhyrx or medical safety roles
• Proven expertise in benefit-risk evaluation and clinical safety assessment
• Experience preparing safety sections of regulatory submissions and PSRs
• Strong track record of leading cross-functional, multicultural teams in a matrix environment
• Fluency in English, strong ability to communicate complex safety topics
Requisitos principales
• base salary with annual range
• performance-based bonus potential
• long-term equity awards
• insurance plans
• retirement plans
• wellbeing resources and global recognition programs
📌 Global Program Safety Lead - CRM (Barcelona)
🏢 Novartis
📍 Barcelona