Safety Leader

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.

The 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 experience within a CRO or Medical Device environment.
• Demonstrated experience supporting Medical Device clinical studies.
• Working knowledge and practical experience with European Medical Device safety requirements and EU safety reporting, including interactions or submissions involving Ethics Committees and Competent Authorities.
• At least 3-5 years of leadership, people-management, or line-management experience.
• Experience leading Safety professionals and managing priorities across multiple programs or studies.
• Experience with client-facing delivery and senior stakeholder management.
• Demonstrated understanding of operational and financial management, including revenue, billing, utilization, budgets, and resource planning.
• Ability to manage competing priorities and make independent operational decisions in a complex, matrixed environment.
• Strong written and verbal communication, presentation, negotiation, and client-management skills.