Experteer Overview
In this role, you drive risk management for lifesaving medicines on a integral scale. You will collaborate with safety leaders and cross-functional teams to shape regulatory-aligned risk plans and deliver high-quality safety documentation. The position emphasizes regulatory excellence, health authority engagement, and process improvement through digital innovation. You will contribute to patient safety and trust in authorities while working in a hybrid setup. This is a high-visibility opportunity to influence safety strategy and global compliance.

Compensaciones / Beneficios
• Drive effective risk management strategies with Global Product Safety leaders and cross-functional partners
• Coordinate the creation and submission of regulatory-compliant Risk Management Plans and Aggregate Reports
• Synchronize content, annexes, and supporting documentation from contributors across functions
• Review safety documents for accuracy, consistency, and regulatory compliance
• Ensure timely development, review, and submission of safety documentation to global health authorities
• Manage Health Authority commitments and track implementation across global and local stakeholders




• Support responses to Health Authority feedback and ensure requirements are implemented
• Provide training and SME on risk management processes and requirements
• Contribute to process improvement, digital innovation, and AI-enabled solutions
• Represent Risk Management in inspections, audits, and quality improvement projects

Responsabilidades
• Minimum 5 years in the pharmaceutical industry (drug safety, clinical research, or regulatory affairs)
• Minimum 1 year of Global RMP management experience in pharma
• Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related field
• Fluent written and spoken English with strong scientific communication and document writing skills
• Strong knowledge of global regulatory requirements, clinical drug development, and pharmacovigilance processes
• Proven ability to collaborate across complex cross-functional teams and manage multiple priorities
• Ability to analyze and translate safety and efficacy data into clear regulatory documentation

Requisitos principales
• hybrid and flexible working options
• minimum 14 weeks paid parental leave
• insurance plans
• retirement plans
• wellbeing resources
• performance-based bonus

📌 Manager Risk Management (Barcelona)
🏢 Novartis
📍 Barcelona