Salary Range:
€105,800.00 - €196,600.00
Job Description Summary
What if your expertise could shape how Novartis builds and manages critical vigilance partnerships across the world?
As Global Head External Vigilance Engagements, you will lead the External Vigilance Engagements team and provide strategic oversight of complex global partnerships, asset transitions and vigilance agreements. You will bring together deep pharmacovigilance and device vigilance expertise, strong leadership and trusted partnership to navigate risk, strengthen regulatory compliance and enable successful external collaborations. Working across Novartis and with external partners, you will have the opportunity to influence at a global level and help ensure patient safety remains at the heart of every engagement.
Location: Barcelona, Spain
#LI-Hybrid
Relocation Support: This role is based in Barcelona, Spain. Novartis is unable to offer relocation support, please only apply if this location is accessible for you.
Job Description
Key Responsibilities
Lead and provide operational oversight of the global External Vigilance Engagements team and outsourced operations.
Shape strategy for external vigilance engagements, including incoming and outgoing assets and partnership transitions.
Oversee negotiation, implementation and ongoing management of global vigilance agreements and external partnerships.
Provide expert guidance on pharmacovigilance and device vigilance requirements for complex contractual arrangements.
Identify compliance risks and ensure effective corrective actions with internal functions and external business partners.
Represent Patient Safety and Pharmacovigilance in strategic business forums, collaborations and external engagements.
Maintain expertise in evolving global pharmacovigilance and device vigilance regulations, standards and guidelines.
Drive inspection and audit readiness, supporting risk assessments, partner audits and regulatory inspections.
Lead training and communication on global standards and procedures governing External Vigilance Engagements.
Build team capabilities and foster effective collaboration across complex global, cross-functional and external partnerships
Essential Requirements
Degree in Biomedical Science or a related scientific discipline.
Minimum eight years’ experience in clinical safety, pharmacovigilance, regulatory or compliance-related areas.
Excellent current knowledge of global pharmacovigilance or device vigilance regulations and guidelines.
Strong understanding of clinical safety reporting requirements and clinical safety database environments.
Proven experience building and leading complex, international and multidisciplinary teams within matrix organizations.
Strong strategic thinking, decision-making, negotiation and problem-solving capabilities.
Excellent influencing and communication skills, with confidence engaging senior internal and external stakeholders.
Fluent written and spoken English, with the ability to work effectively across diverse cultures and global teams.
Desirable
Higher degree in Biomedical Science or a related scientific discipline.
Knowledge of additional languages beyond English
Ready to bring your leadership and vigilance expertise to a role with truly global impact?
Join us to shape trusted external partnerships, strengthen patient safety and help navigate some of our most complex strategic engagements. Apply today and help us reimagine medicine together.
Rewards
At Novartis, we’re committed to reimagining medicine together and rewarding the people who make it happen.
The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and a minimum of 14 weeks paid parental leave.
Expected…