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Director, MedTech Safety - Europe
Trabajo disponible en:
Cataluña, 08001, Barcelona, Cataluna, España
Publicado en 2026-11-04
Empresa:
IQVIA
Tiempo completo
puesto Publicado en 2026-11-04
Especializaciones laborales:
-
Gerencia
Analista de cumplimiento, Gerente de Operaciones, Gerente de Proyecto, Gerente de Contratos
Descripción del trabajo
IQVIA Med Tech is seeking an experienced Safety leader to oversee a growing team responsible for safety activities supporting Medical Device clinical studies in Europe. This role will provide both technical and operational leadership, with primary responsibility for EU medical-device safety reporting, team management, client delivery, financial oversight, and the continued development of the Safety organization as the portfolio grows.
This leader will initially oversee and help build a team that is responsible for expedited and periodic safety reporting to European Ethics Committees and Competent Authorities, annual progress reporting.
Essential Functions Medical Device Safety Leadership- Provide senior leadership and oversight for safety activities supporting Medical Device clinical studies, with a particular focus on studies conducted in Europe.
- Ensure appropriate execution of expedited and periodic safety reporting to EU Ethics Committees and Competent Authorities.
- Oversee preparation and delivery of annual and periodic safety/progress reports.
- Serve as a senior Safety subject matter expert for clients, internal stakeholders, operational teams, and integrated partners.
- Provide guidance on European Medical Device safety requirements and ensure operational processes meet applicable regulatory, contractual, quality, and reporting requirements.
- Partner with US Safety team and cross-functional leaders to resolve complex operational, regulatory, and client issues.
- Lead, develop, and manage a team of Safety Specialists and Safety Managers.
- Support the continued build-out of the Safety organization as additional positions are approved and client work expands.
- Provide day-to-day leadership, coaching, workload oversight, performance management, and professional development.
- Ensure appropriate staffing, resource allocation, utilization, training, and operational readiness across the team.
- Establish clear accountability for quality, timelines, compliance, and client delivery.
- Foster a collaborative, solutions-oriented culture focused on accountability, ownership, and continuous improvement.
- Serve as a senior point of contact for assigned clients and programs, establishing strong and trusted client relationships.
- Oversee scope, objectives, timelines, quality, and delivery for assigned Safety programs.
- Ensure appropriate communication and escalation channels are maintained with clients and internal stakeholders.
- Lead resolution of significant quality concerns, operational issues, and customer escalations.
- Partner with customers to establish working practices, KPIs, SLAs, quality expectations, and processes for ongoing oversight.
- Provide strategic consultation regarding Safety delivery and recommend solutions based on evolving client and program requirements.
- Represent Safety in governance meetings, steering committees, operational reviews, and other high-visibility client forums.
- Provide oversight of the financial and operational performance of assigned Safety work.
- Manage and monitor revenue, billing, utilization, budgets, resourcing, and financial performance.
- Ensure resources and staffing plans remain aligned with current and anticipated client demand.
- Monitor program-level quality, productivity, utilization, and financial metrics and implement corrective actions when needed.
- Support adherence to change-control processes and ensure changes in scope are appropriately assessed, documented, and reflected financially.
- Partner with operational and commercial stakeholders as the team's responsibilities and book of business evolve.
- Identify opportunities for repeat business and additional client services based on…
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