Associate Director, Aggregate Reports & Risk Management
Novartis Barcelona
Experteer Overview
In this role you will lead global Aggregate Reports u0026amp; Risk Management (ARRM) operations to support patient safety and regulatory compliance. You will collaborate across geographies to schedule, deliver, and improve ARRM outputs, drive audits and inspections readiness, and guide the adoption of innovative solutions including AI-enabled tools.You’ll mentor the ARRM team, oversee transitions of new activities, and partner with Country Organisations and cross-functional teams to ensure timely, high-quality reporting. This is a pivotal role shaping safety processes at scale within Novartis.
Compensaciones / Beneficios- Lead ARu0026RM activities across the product portfolio with coordination, scheduling, and delivery to Country Organisations
- Maintain and execute the global aggregate reporting schedule with Country Organisations and global line functions
- Ensure quality and compliance of aggregate reports, risk management plans, and commitments, including root cause analysis and CAPA implementation
- Monitor operational KPIs and lead audit/inspection readiness, including Health Authority inspections
- Serve as operational interface between ARu0026RM, Country Organisations, and cross-functional stakeholders
- Represent the organisation externally as an operational lead in stakeholder interactions
- Drive operational excellence and lead global PSu0026PV initiatives to enhance processes, systems, and delivery
- Lead transition and integration of new ARu0026RM activities and support implementation of AI-enabled tools
- Oversee onboarding, training, and mentoring of ARu0026RM associates to strengthen team capability
- Deputise for line manager and support recruitment and team development activities
- Degree in Life Sciences, Pharmacy, Medical Sciences, or related scientific discipline
- Minimum 7 years of experience in pharmaceutical/biotech/healthcare
- Proven experience leading complex cross-functional programs or business transformations
- Intermediate knowledge of pharmacovigilance, drug development, regulatory and business requirements
- Experience leveraging AI/digital technologies to improve decision-making and efficiency
- Ability to influence senior stakeholders and build consensus across diverse organisations
- Excellent project planning, prioritization, and execution skills with strong attention to detail
- Strong communication, collaboration, negotiation, and stakeholder management skills
- Experience with project management and collaboration tools incl. Microsoft Project, SharePoint, Teams, and Microsoft Office
- Fluent English (written and spoken); additional languages advantageous
- flexible and hybrid working options
- minimum 14 weeks paid parental leave
- insurance plans
- retirement plans
- wellbeing resources
- global recognition programs
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