Director, MedTech Safety - Europe

5PY IQVIA RDS Inc.; Warszawa; On-site; PLN 310,000 - 659,000; Full time

Job summary

IQVIA MedTech is seeking an experienced Safety leader to oversee a growing European team responsible for medical device safety activities across clinical studies. The role combines technical and operational leadership to ensure EU safety reporting, quality and client delivery.

You will build and mentor Safety Specialists and Managers, drive staffing, budgets and performance, and partner with the US Safety team to resolve complex regulatory and client issues.

Qualifications

• Bachelor's degree in health science or related field, or equivalent experience.
• 10+ years of progressive Safety or clinical safety experience in CRO or Medical Device environment.
• Experience supporting Medical Device clinical studies in Europe.
• Knowledge of EU medical device safety requirements and EU safety reporting to Ethics Committees and Competent Authorities.
• 3–5 years of leadership/people-management experience.
• Experience leading Safety professionals and managing priorities across multiple programs or studies.

Responsibilities

• Provide senior leadership for safety activities supporting European studies.
• Oversee expedited and periodic EU safety reporting to Ethics Committees and Authorities.
• Oversee preparation and delivery of annual and periodic safety/progress reports.
• Serve as a Safety SME for clients, internal stakeholders, operational teams, and partners.
• Provide guidance on European Medical Device safety requirements and ensure compliance with regulatory, contractual, quality, and reporting requirements.
• Partner with US Safety team and cross-functional leaders to resolve complex issues.
• Lead, develop, and manage a team of Safety Specialists and Safety Managers.
• Support staffing, resource allocation, and budgeting for safety programs.
• Represent Safety in governance meetings, steering committees, and client forums.

Skills

Safety leadership

European regulatory knowledge

Leadership and people management

Client relationship management

Strategic program leadership

Operational management

Education

Bachelor's degree in health science or related field

Job 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.

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 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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is zł310,300.00 - zł659,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses and/or other forms of compensation may be offered, in addition to a range of health and welfare and other benefits.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments.

Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Thank you for your interest in growing your career with us.

Learn more at https://jobs.iqvia.com