Risk & Compliance Lead (PV/Safety)

Risk & Compliance Lead (PV/Safety)

About ICON

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

As a Risk & Compliance Lead at ICON, you will support the delivery of quality, risk and compliance activities within our Safety operations.

This is an excellent opportunity for someone with experience in a regulated pharmaceutical, clinical research, Pharmacovigilance, Drug Safety, Quality or Compliance environment who enjoys using data and operational insight to identify risk, resolve quality issues and drive continuous improvement.

You will work closely with operational teams, supporting them in identifying emerging risks, managing quality events and maintaining high standards of compliance.

What You Will Do

Your focus will be on monitoring risk and compliance, supporting the effective management of quality events and helping operational teams identify and resolve issues.

Key responsibilities include:

• Monitor agreed quality and compliance metrics, identifying risks, trends and outliers and escalating potential non-compliance or areas requiring further action.
• Provide focused review and analysis of metrics for specific clients or projects when required.
• Support operational teams with the management of Quality Events, including deviations, Corrective and Preventive Actions (CAPAs) and audit findings.
• Support investigations and Root Cause Analysis (RCA), helping to identify underlying causes and appropriate corrective and preventive actions.
• Assist operational teams with audit and inspection readiness, including preparation for and support during client audits and regulatory inspections.
• Support the effective management and resolution of audit and inspection findings, working collaboratively with relevant stakeholders.
• Contribute to system and process optimisation initiatives, using quality data and operational insight to identify opportunities for improvement.
• Work cross-functionally to promote strong risk awareness and a culture of quality, compliance and continuous improvement.

Your Profile

You will bring experience from a regulated environment, ideally within pharmaceutical, clinical research, Pharmacovigilance, Drug Safety, Quality or Compliance, combined with an understanding of how quality and regulatory requirements translate into operational delivery.

You will ideally have:

• Bachelor’s degree in life sciences, pharmacy, healthcare, law, business, quality, risk management, or a related field. A professional certification in quality, risk management or compliance is an advantage.
• Relevant experience within Pharmacovigilance, Drug Safety, Quality, Compliance or another regulated pharmaceutical or clinical research environment.
• A good understanding of regulated operational processes and associated quality and compliance requirements.
• Experience working with quality metrics, deviations, CAPAs, audit findings and Root Cause Analysis.
• Exposure to audits, inspections, compliance reviews or inspection-readiness activities.
• Strong analytical and problem-solving skills, with the ability to identify trends, outliers and areas of potential risk.
• The ability to work collaboratively with operational teams to investigate issues and develop practical, sustainable solutions.
• Strong communication and stakeholder management skills, with the confidence to raise and escalate risks appropriately.
• The ability to manage competing priorities and follow actions through to resolution.
• A proactive approach to continuous improvement, quality and compliance.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.