Director, Medtech Safety

IQVIA MedTech 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.
Team Leadership
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.
Client and Program Leadership
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.
Operational and Financial Management
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.
Business and Strategic Leadership
Identify opportunities for repeat business and additional client services based on customer needs.
Participate in RFPs, proposals, solution development, budgeting, and customer presentations.
Provide Safety subject-matter expertise in the development of operational solutions for new opportunities.
Assess the operational feasibility, staffing requirements, regulatory considerations, and financial impact of proposed solutions.
Support development and negotiation of scopes of work, budgets, work orders, service-level agreements, and other applicable contractual documentation.
Lead or contribute to global initiatives designed to improve Safety delivery, processes, systems, oversight, and service offerings.
Collaborate across functions to develop practical solutions and ensure consistent delivery across programs and geographies.
Qualifications
Required
Bachelor's degree, preferably in a health science, life science, nursing, pharmacy, or related discipline, or an equivalent combination of education, training, and relevant experience.
At least 10 years of progressive Safety, clinical safety, or related experienc