21 ott - Italia
Biomapas
(Senior) Director Pharmacovigilance Operations/Central PV Services is responsible for the leadership, strategic development, and operational oversight of the global Central Pharmacovigilance (PV) Services organization. The role ensures compliant, efficient, and scalable delivery of centralized pharmacovigilance services, including Individual Case Safety Report (ICSR) processing, literature surveillance, signal detection and management, vantaggi-risk management, aggregate safety reporting, and related PV operational services. The role is accountable for building and expanding strategic global delivery hubs, developing scalable outsourcing models, driving operational excellence, and supporting the operational, financial, and client objectives of the PV & MI Business Unit.
This is remote role for anyone within European Union.
Key areas of responsibility and main tasks:Strategic & Functional Leadership
• Execute the Central PV Services strategy in alignment with the PV & MI Business Unit objectives.
• Develop scalable centralized PV operating models supporting global clinical development and post-marketing programs.
• Lead establishment, expansion and optimization of global PV delivery hubs.
• Develop strategic outsourcing models to improve scalability, quality, operational efficiency, and financial performance.
• Drive innovation, automation, AI-enabled technologies and digital transformation across Central PV Services.
• Advise the VP, Global Safety & MI on operational strategy, service delivery, capacity planning and operational risks.
• Act as escalation point for significant Central PV operational and service delivery issues.
• Provide operational performance reporting, delivery metrics and strategic updates to senior management.
Central PV Operations & Delivery Excellence
• Provide strategic and operational oversight of centralized pharmacovigilance services across:
• Case Management (ICSR processing, case intake and triage, medical coding, quality review, and m
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