Salary Range:
€69,100.00 - €128,300.00

Job Description Summary
LI-Hybrid
Location: Barcelona, Spain

This role is based in Barcelona, Spain. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you.

The Regional PV QA Head provides end to end quality assurance vigilance expertise and support to global and local operational Pharmacovigilance (PV) and Device Vigilance activities within Novartis with a focus on the country organizations, as well as quality expertise in regional and local vigilance regulation, in order to ensure compliance with applicable regulatory requirements and Novartis procedures.

Job Description
Major Accountabilities:
• Drive independently the regional and country quality oversight for implementation and maintenance of Novartis vigilance Quality Systems performed by the local teams, namely Quality Issue, proactive risk assessment and action management systems.
• Ensure, together with PS and PV in Countries and Regions team,



that regional and country quality performance of the Novartis Vigilance System tasks and responsibilities is performed as required under integral, regional and country PV regulations, to monitor that safety of the Novartis authorized products are met, and changes to their risk-benefit balance are identified.
• Support the regional and country Global Research and Development Quality management cycle through development, execution and accountability for deliverables of the global vigilance Quality Plan (QP). Coordinate execution of the QP with relevance to applicable regional and country patient safety activities and report the status to applicable Global PV QA team.
• Monitor indicators that relate to the performance, compliance and quality of regional and country vigilance systems, in line with indicators defined by Global PV QA team. Act as a quality champion by communicating risks to PS and PV and providing recommendations on potential mitigations Promptly commu

📌 Regional Head, Pharmacovigilance Quality (Barcelona)
🏢 Novartis
📍 Barcelona