Associate Director, Aggregate Reports & Risk Management
3 days ago
Sabadell
Salary Range: €63,600.00 - €118,000.00 (Band Level 5) Location: Barcelona, Spain | Working Model: Hybrid | Relocation Support: None – role based in Barcelona. Job Overview Associate Director, Aggregate Reports & Risk Management – you will lead AR & RM operations, ensuring compliance, operational excellence, and cross-functional collaboration across the product portfolio. Responsibilities • Lead AR & RM operational activities across the product portfolio, ensuring effective coordination, scheduling, assignment, and delivery to Country Organisations., • Develop and maintain the global aggregate reporting schedule in collaboration with Country Organisations and global line functions., • Ensure quality and compliance of aggregate reports, risk management plans, and commitments, including driving investigations, root cause analysis, and CAPA implementation., • Monitor operational KPIs and lead audit and inspection readiness activities, including Health Authority inspections and regulatory compliance requirements., • Act as key operational interface between AR & RM, Country Organisations, and cross-functional stakeholders to ensure alignment and seamless collaboration., • Represent the organisation externally as an operational lead in interactions with relevant stakeholders and partners., • Drive operational excellence and lead global PS & PV initiatives to enhance processes, systems, and delivery of AR & RM activities., • Lead the transition and integration of new AR & RM activities and support implementation of innovative solutions, including AI-enabled tools., • Lead onboarding, training, and mentoring of AR & RM associates to strengthen team capability and performance., • Deputise for the line manager and support recruitment and team development activities. Qualifications • Degree in Life Sciences, Pharmacy, Medical Sciences or related scientific discipline., • Minimum 7 years of experience in the pharmaceutical, biotechnology or healthcare industry., • Proven experience leading complex cross-functional programs, projects or business transformation initiatives., • Intermediate knowledge of pharmacovigilance, drug development, regulatory and business requirements., • Demonstrated ability to leverage Artificial Intelligence and digital technologies to enhance decision-making, efficiency and outcomes., • Proven ability to influence senior stakeholders and build consensus across diverse organisations., • Excellent project planning, prioritisation and execution skills 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 applications., • Fluent in English (spoken and written); additional languages are an advantage. Desirable Skills • Knowledge of Novartis organisational structure, processes and ways of working., • Expertise in project management methodologies such as Lean Six Sigma, Agile or related approaches. #J-18808-Ljbffr