03 ago
|
Novartis
|
Barcelona
03 ago
Novartis
Barcelona
Experteer Overview
Obtenga más información sobre las tareas generales relacionadas con esta oportunidad a continuación, así como sobre las habilidades requeridas.
In this role, you drive risk management for lifesaving medicines on a global 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 / Incentivos
- 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 xugodme 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