raffaella mura

I’m a senior pharmacovigilance professional with 15+ years of experience in global drug safety operations within a multinational pharmaceutical environment. I bring deep expertise in ICSR lifecycle management, pharmacovigilance systems (ArisGlobal LSMV), vendor governance, and regulatory compliance (GVP, ICH).

Since 2021, I’ve led Global Pharmacovigilance Specialist work at Menarini Group, overseeing outsourced pharmacovigilance activities (vendor management) to ensure compliance with global regulatory requirements and internal procedures. I coordinate end-to-end ICSR lifecycle across global markets, monitor regulatory timelines and safety case processing KPIs, and support audit and inspection readiness, including CAPA implementation and follow-up. I also author and maintain SOPs/Working Instructions aligned with GVP modules, manage deviations and quality issues, and train and onboard new personnel while collaborating with cross-functional teams (medical, regulatory, quality, IT).

From 2008 to 2021, as Safety Data Manager, I managed full lifecycle ICSR work—data entry, MedDRA and WHO Drug coding, narrative writing, quality control, and regulatory reporting to EudraVigilance and partners. I handled duplicate detection and case reconciliation per GVP requirements, supported deviation handling and quality processes, and ensured partner/local safety unit reconciliation across multiple regions.