Associate Director, Aggregate Reports & Risk Management
hace 2 días
Sabadell
ppSalary Range: €63,600.00 - €118,000.00 (Band Level 5) /ppLocation: Barcelona, Spain | Working Model: Hybrid | Relocation Support: None – role based in Barcelona. /ph3Job Overview /h3pAssociate Director, Aggregate Reports Risk Management – you will lead AR RM operations, ensuring compliance, operational excellence, and cross-functional collaboration across the product portfolio. /ph3Responsibilities /h3ulliLead AR RM operational activities across the product portfolio, ensuring effective coordination, scheduling, assignment, and delivery to Country Organisations. /liliDevelop and maintain the global aggregate reporting schedule in collaboration with Country Organisations and global line functions. /liliEnsure quality and compliance of aggregate reports, risk management plans, and commitments, including driving investigations, root cause analysis, and CAPA implementation. /liliMonitor operational KPIs and lead audit and inspection readiness activities, including Health Authority inspections and regulatory compliance requirements. /liliAct as key operational interface between AR RM, Country Organisations, and cross-functional stakeholders to ensure alignment and seamless collaboration. /liliRepresent the organisation externally as an operational lead in interactions with relevant stakeholders and partners. /liliDrive operational excellence and lead global PS PV initiatives to enhance processes, systems, and delivery of AR RM activities. /liliLead the transition and integration of new AR RM activities and support implementation of innovative solutions, including AI-enabled tools. /liliLead onboarding, training, and mentoring of AR RM associates to strengthen team capability and performance. /liliDeputise for the line manager and support recruitment and team development activities. /li /ulh3Qualifications /h3ulliDegree in Life Sciences, Pharmacy, Medical Sciences or related scientific discipline. /liliMinimum 7 years of experience in the pharmaceutical, biotechnology or healthcare industry. /liliProven experience leading complex cross-functional programs, projects or business transformation initiatives. /liliIntermediate knowledge of pharmacovigilance, drug development, regulatory and business requirements. /liliDemonstrated ability to leverage Artificial Intelligence and digital technologies to enhance decision-making, efficiency and outcomes. /liliProven ability to influence senior stakeholders and build consensus across diverse organisations. /liliExcellent project planning, prioritisation and execution skills with strong attention to detail. /liliStrong communication, collaboration, negotiation and stakeholder management skills. /liliExperience using project management and collaboration tools, including Microsoft Project, SharePoint, Teams and Microsoft Office applications. /liliFluent in English (spoken and written); additional languages are an advantage. /li /ulh3Desirable Skills /h3ulliKnowledge of Novartis organisational structure, processes and ways of working. /liliExpertise in project management methodologies such as Lean Six Sigma, Agile or related approaches. /li /ul /p #J-18808-Ljbffr