Lead PV Compliance Manager

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
 

As a Lead PV Compliance Manager you will be dedicated to one of our pharmaceutical clients with a truly global presence. Our commitment to compliance promotes confidence in ICON, our client, and, ultimately, their products for patients who need them. The program is ideal for individuals who thrive in a continually-evolving culture that mirrors ICON’s commitment to career development.

Working as part of our global Compliance group, you take responsibility for managing compliance activities around the world to help drive our strategic vision for continual improvement.

Key responsibilities include:

• Manage the investigation of ICSR reporting non-compliance with various internal and external stakeholders. Review and assess the root cause and corrective/preventative actions that are proposed.
• Respond to ICSR compliance queries and requests from License Partners for root cause and CAPA information.
• Perform analysis of trends in non-compliance and report to client for appropriate action(s).
• Compile monthly compliance metrics for reporting of ICSRs to License Partners.
• Oversee compliance of Local PV ICSR reporting to Global Patient Safety Evaluation.
• Prepare compliance data for audits and inspections and ensure audit readiness, support and address findings as needed
• Compile responses to business partner audit questionnaires and ensure timely delivery to concerned stakeholders

Qualifications

• Previous experience in PV case processing
• Demonstrable experience using global safety databases, ideally Argus
• At least an undergraduate degree in a life-sciences discipline
• Strong Excel skills
• A common-sense and methodical approach to your work

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and 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, because of a medical condition or disability, 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 through the form below.

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