(Senior) Director Pharmacovigilance Operations
Pubblicato il 29-10-2026 - Biomapas Group in Roma
(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, benefit-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.
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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 medical review support).
Literature Management (literature surveillance, screening, and literature case processing).
Signal & Benefit-Risk Management (signal detection, validation, evaluation, benefit-risk assessment, and related risk management activities).
Aggregate Safety Reporting (PSURs/PBRERs, DSURs, PADERs, and other regulatory aggregate safety reports).
Operational Excellence (Safety Data Exchange activities, operational metrics and reporting, process standardization, automation, continuous improvement, and service delivery governance).
Ensure all Central PV Services are delivered in accordance with applicable regulations, contractual obligations, internal procedures, quality standards, and client expectations.
Monitor operational, quality, and productivity KPIs, ensuring timely escalation, corrective actions, and continuous improvement initiatives.
Drive operational excellence through standardized processes, technology enablement, automation, and scalable delivery models that support sustainable business growth
Global Delivery Hub & Outsourcing Strategy
Develop and implement the global strategy for centralized PV delivery, ensuring scalable, efficient, and consistent service delivery across regions.
Build, expand, and optimize strategic centralized PV delivery hubs to support business growth and evolving client needs.
Lead the transition and integration of PV activities into centralized delivery models, ensuring effective governance, business continuity, and operational consistency.
Establish standardized operating models, resource planning, and workforce strategies to optimize capacity, utilization, and delivery performance across global operations.
Drive continuous improvement through process optimization, innovation, digital solutions, and enabling technologies to enhance quality, efficiency, and scalability.
Develop and maintain resilient global delivery capabilities that support sustainable growth, client satisfaction, and high-quality service delivery
Compliance & Operational Quality
Maintain inspection-ready Central PV operational processes.
Ensure delivery complies with EU GVP Modules, FDA, ICH and other applicable global regulations.
Support regulatory inspections and client audits involving Central PV Services.
Oversee implementation and follow-up of CAPAs related to operational activities.
Ensure governance of operational KPIs, quality metrics and compliance monitoring.
Collaborate with QPPV Office, Medical/Clinical Safety, PV/MI Technologies, and Medical Information functions to e