Experteer Overview

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In this role, you drive global Aggregate Reports u0026amp; Risk Management operations to support patient safety. You will coordinate delivery across country organizations, ensure report quality and regulatory compliance, and guide risk management activities. You’ll lead cross-functional programs, foster audit readiness, and implement innovative solutions, including AI-enabled tools. This is a chance to influence safety processes at scale and shape our PSu0026amp;PV initiatives.

Compensaciones / Beneficios

- Lead ARu0026RM operational activities across the product portfolio, coordinating scheduling, assignment, and delivery to Country Organisations
- Develop and maintain the global aggregate reporting schedule with Country Organisations and global functions for timely execution
- Ensure quality and compliance of aggregate reports, risk management plans, and commitments, including investigations and CAPA implementation
- Monitor operational KPIs and lead audit and inspection readiness activities, including Health Authority inspections
- Act as operational interface between ARu0026RM, Country Organisations, and cross-functional stakeholders to ensure alignment
- Represent the organisation externally as an operational lead with stakeholders and partners
- Drive operational excellence and integral PSu0026PV initiatives to improve processes, systems,



and delivery of ARu0026RM activities
- Lead the transition and integration of new ARu0026RM activities and support implementation of AI-enabled tools
- Lead onboarding, training, and mentoring of ARu0026RM associates to strengthen team capability

Responsabilidades

- Degree in Life Sciences, Pharmacy, Medical Sciences, or related scientific discipline
- Minimum 7 years of experience in pharmaceutical, biotechnology, or healthcare industry
- Experience leading complex cross-functional programs or business transformation initiatives
- Intermediate knowledge of pharmacovigilance, drug development, regulatory and business requirements
- Demonstrated ability to leverage AI and digital technologies to enhance decision-making and outcomes xugodme
- Proven ability to influence senior stakeholders and build consensus across diverse organizations
- Excellent project planning, prioritization, and execution with strong attention to detail
- Strong communication, collaboration, negotiation, and stakeholder management skills
- Experience using project management and collaboration tools including Microsoft Project, SharePoint, Teams, and Microsoft Office
- Fluent English in speaking and writing
- Additional languages are an advantage

Requisitos principales

- insurance plans
- retirement plans
- wellbeing resources
- global recognition programs
- flexible and hybrid working options
- minimum 14 weeks paid parental leave

📌 Associate Director, Aggregate Reports & Risk Management (Barcelona)
🏢 Novartis
📍 Barcelona