03 ago
|
Novartis
|
Barcelona
03 ago
Novartis
Barcelona
Experteer Overview In this role you will advance patient safety by shaping global risk management strategies and ensuring regulatory-compliant safety documentation. You will collaborate with safety leaders and cross-functional teams to drive evidence-based risk plans, aggregate reports, and timely submissions to health authorities. The position offers high visibility and impact across global stakeholders, with opportunities to contribute to process improvements and AI-enabled solutions. This is a mission-driven opportunity to help reimagine medicine and protect patients worldwide.Compensaciones / Beneficios
- Partner with Global Product Safety Leaders and cross-functional teams to drive risk management strategies
- Lead coordination and delivery of high-quality, regulatory-compliant Risk Management Plans and Aggregate Reports
- Coordinate contributors across functions to secure quality content and documentation
- Review risk management documents for consistency, accuracy, and regulatory compliance
- Ensure timely development, review, and submission of safety documentation to global health authorities
- Manage Health Authority commitments and track implementation with general and local stakeholders
- Support responses to Health Authority feedback and ensure approved requirements are implemented
- Provide training, guidance, and SME on risk management processes
- Contribute to process improvement, digital innovation, and AI-enabled solutions
- Represent Risk Management in inspections, audits, and cross-functional quality improvement projectsResponsabilidades
- Minimum 5 years in the pharmaceutical industry (drug safety, clinical research, or regulatory affairs)
- Minimum 1 year of Global RMP management experience within the pharmaceutical industry
- Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related field
- Fluent English (written and spoken) with strong scientific communication and document-writing skills
- Strong knowledge of integral regulatory requirements, clinical drug development, and pharmacovigilance
- Proven ability to collaborate across cross-functional teams and manage multiple priorities
- Ability to analyze and translate safety/efficacy data into regulatory documentationRequisitos principales
- insurance plans
- retirement plans
- wellbeing resources
- global recognition programs
- versátil and hybrid working options
- minimum 14 weeks paid parental leave
📌 Manager Risk Management (Barcelona)
🏢 Novartis
📍 Barcelona