30 ott - Italia
Biomapas Group
p(Senior) bDirector /b bPharmacovigilance Operations /b/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. /p pThis is bremote /b role for anyone within bEuropean Union. /b /p h3Key areas of responsibility and main tasks: /h3 h3Strategic Functional Leadership /h3 ul liExecute the Central PV Services strategy in alignment with the PV MI Business Unit objectives. /li liDevelop scalable centralized PV operating models supporting global clinical development and post-marketing programs. /li liLead establishment, expansion and optimization of global PV delivery hubs. /li liDevelop strategic outsourcing models to improve scalability, quality, operational efficiency, and financial performance. /li liDrive innovation, automation, AI-enabled technologies and digital transformation across Central PV Services. /li liAdvise the VP, Global Safety MI on operational strategy, service delivery, capacity planning and operational risks. /li liAct as escalation point for significant Central PV operational and service delivery issues. /li liProvide operational performance reporting, delivery metrics and strategic updates to senior management /li /ul h3Central PV Operations Delivery Excellence /h3 ul liProvide strategic and operational oversight of centralized pharmacovigilance services across: /li liCase Management (ICSR processing, case intake and triage, medical coding, quality review, and medical review support). /li liLiterature Management (literature surveillance, screening, and literature case processing). /li liSignal Benefit-Risk Management (signal detection, validation, evaluation, benefit-risk assessment, and related risk management activities). /li liAggregate Safety Reporting (PSURs/PBRERs, DSURs, PADERs, and other regulatory aggregate safety reports). /li liOperational Excellence (Safety Data Exchange activities, operational metrics and reporting, process standardization, automation, continuous improvement, and service delivery governance). /li liEnsure all Central PV Services are delivered in accordance with applicable regulations, contractual obligations, internal procedures, quality standards, and client expectations. /li liMonitor operational, quality, and productivity KPIs, ensuring timely escalation, corrective actions, and continuous improvement initiatives. /li liDrive operational excellence through standardized processes, technology enablement, automation,
and scalable delivery models that support sustainable business growth /li /ul h3Global Delivery Hub Outsourcing Strategy /h3 ul liDevelop and implement the global strategy for centralized PV delivery, ensuring scalable, efficient, and consistent service delivery across regions. /li liBuild, expand, and optimize strategic centralized PV delivery hubs to support business growth and evolving client needs. /li liLead the transition and integration of PV activities into centralized delivery models, ensuring effective governance, business continuity, and operational consistency. /li liEstablish standardized operating models, resource planning, and workforce strategies to optimize capacity, utilization, and delivery performance across global operations. /li liDrive continuous improvement through process optimization, innovation, digital solutions, and enabling technologies to enhance quality, efficiency, and scalability. /li liDevelop and maintain resilient global delivery capabilities that support sustainable growth, client satisfaction, and high-quality service delivery /li /ul h3Compliance Operational Quality /h3 ul liMaintain inspection-ready Central PV operational processes. /li liEnsure delivery complies with EU GVP Modules, FDA, ICH and other applicable global regulations. /li liSupport regulatory inspections and client audits involving Central PV Services. /li liOversee implementation and follow-up of CAPAs related to operational activities. /li liEnsure governance of operational KPIs, quality metrics and compliance monitoring. /li liCollaborate with QPPV Office, Medical/Clinical Safety, PV/MI Technologies, and Medical Information functions to ensure harmonized PV/MI governance /li /ul h3Financial Business Support /h3 ul liContribute to Business Unit financial targets through effective operational planning, workforce optimization and resource forecasting. /li liSupport pricing, proposals, RFIs, RFPs and bid defenses by providing operational expertise, delivery models and resource assumptions. /li liIdentify opportunities for operational efficiencies, automation and cost optimization while maintaining quality and compliance. /li liSupport expansion of Central PV Services across existing and new clients. /li /ul h3Team Management /h3 ul liLead and develop the Central PV Services leadership team. /li liBuild organizational capability supporting global service expansion. /li liDrive succession planning and talent development. /li liPromote a culture of operational excellence, accountability, innovation and continuous improvement.
/li liEnsure appropriate organizational structures supporting sustainable growth /li /ul h3Client Cross-Functional Collaboration /h3 ul liSupport client retention through high-quality operational delivery and continuous service improvement. /li liPartner closely with the QPPV Office, Program Management, Operations Strategy, PV/MI Technologies, Medical Clinical Safety and Medical Information to ensure integrated service delivery. /li liCollaborate with Quality, Regulatory, Commercial, Legal and Business Development functions. /li liRepresent Central PV Services during governance meetings, operational reviews and client engagements. /li liSupport strategic client initiatives involving centralized PV outsourcing and transformation /li /ul h3Other Responsibilities /h3 ul liIdentify areas for improvement and proactively propose solutions within the area of responsibility. /li liDeputize for another employee or staff member of the same department as instructed by the Head of Department. /li /ul pPerform additional tasks related to the department's activities as assigned by the Head of Department /p h3Requirements /h3 pMD, PharmD, PhD, MSc or equivalent scientific degree preferred. /p ul liAt least 12 years of pharmacovigilance experience. /li liAt least 5 years of progressive leadership experience managing global PV operations. /li liDemonstrated experience leading centralized PV services and global delivery organizations. /li liExtensive knowledge of case processing, literature surveillance, signal detection, vantaggi-risk management and aggregate reporting. /li liExperience building global shared service centers and scalable outsourcing models. /li liStrong knowledge of EU GVP Modules, ICH guidelines, FDA and global PV regulations. /li liExperience supporting regulatory inspections and client audits. /li liStrong understanding of safety databases and PV technologies. /li liDemonstrate strong leadership and collaboration by effectively leading and aligning global operational teams. /li liDrive executive communication through operational excellence and strategic execution. /li liInfluence stakeholders across complex global organizations. /li liDemonstrate strategic thinking with a strong operational excellence mindset. /li liApply advanced decision-making and problem-solving skills. /li liDemonstrate negotiation skills and commercial acumen with a client-focused approach. /li liStay informed of emerging PV technologies, automation, AI, and regulatory developments. /li liEffectively adapt to and lead organizational change. /li liApply coaching and mentoring techniques to develop future leaders. /li liDemonstrate behaviors aligned with Company values, cultural awareness, and the ability to work effectively in diverse environments /li liProfessional level in English, both oral and written /li /ul h3Benefits /h3 ul liInternational team and environment /li liRemote Work, workation Flexibility /li liHealth Wellbeing - wellness initiatives /li liProfessional growth and development in the Life science industry /li liTeam Culture - Team buildings and global meetings /li liPerformance based annual bonus /li liComprehensive Insurance - Personal accident, business trip coverage, and additional health insurance /li /ul #J-18808-Ljbffr