# Safety Leader **Company**: IQVIA **Location**: Warsaw **Experience**: senior **Job type**: full-time **Salary**: zł310,300.00 - zł659,300.00 **Category**: Healthcare **Industry**: Healthcare **Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Warsaw-Poland/Director--MedTech-Safety---Europe_R1567079?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_998590d6-692 ## Description 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. ## Skills ### Required - European Medical Device safety requirements - EU safety reporting - leadership - team management - client delivery - financial oversight --- Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Warsaw-Poland/Director--MedTech-Safety---Europe_R1567079?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)