Associate Director, PV QA - Data & Digital
Novartis · Barcelona, Catalonia, ES
Job Description Summary The Associate Director, Pharmacovigilance QA - Data & Digital leads PVQA Data and Digital strategy and initiatives to support quality...
Job description
Job Description Summary The Associate Director, Pharmacovigilance QA - Data & Digital leads PVQA Data and Digital strategy and initiatives to support quality assurance oversight of end-to-end Pharmacovigilance (PV) and Device Vigilance (DV) activities within Novartis to ensure compliance with applicable local and global regulatory requirements and Novartis procedures and quality standards. Job Description: Major Accountabilities: Lead PV QA Data and Digital strategy and initiatives to drive operational excellence, and insight-driven decision-making to maintain or improve quality performance and compliance of Novartis PV activities including ICSR management, aggregate reporting, medical safety, risk management, Health Authority reporting, PV IT systems and device vigilance. Act as a quality Artificial Intelligence (AI) champion and Innovation Lead representing PVQA across RDQ, Quality, and PS&PV Data & Digital related networks and initiatives, to influence strategy and ensure alignment. By championing capability building in AI, automation, and compliant change management. proactively propose potential quality improvement measures and develop strategies aimed at simplifying processes...