Director of Pharmacovigilance Quality Assurance

ROLE: Director of Pharmacovigilance Quality Assurance

LOCATIONS: Sofia, Bulgaria OR Reading, UK

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Director of PVQA is responsible for the development and oversight of execution of the global PV QA audit strategy and has direct line management oversight of the team who will execute that strategy. Partners with Pharmacovigilance & Safety Services to provide guidance when needed related to regulatory compliance and will engage with them to support process improvement. Understands and interprets regulatory requirements and guidance related to Good Pharmacovigilance Practices (GVP). Is responsible for communicating audit results to QA Management and internal customers and supporting the PV functions with CAPA development. Will represent QA as an assigned business partner to Pharmacovigilance & Safety Services

To be successful in the role, you will have:

• Have knowledge and experience necessary to develop the annual global audit plan.
• Ability to analyze QA audit results and operational data to identify trends and suggest improvements.
• Strong people leader skills
• Advanced knowledge and understanding of drug development and both the Good Clinical Practice (GCP) and GVP regulatory requirements.
• Strong communication skills and ability to articulate QA strategy to internal and external stakeholders.
• Experience using quality management system software to manage the audit program.

To do this job, you would need:

• Bachelor’s Degree or equivalent in life sciences.
• A minimum of 8-10 years GCP QA experience, with experience in pharmacovigilance QA or direct pharmacovigilance experience combined with GCP QA experience.  
• Demonstrated in-depth knowledge of major regulatory authority pharmacovigilance regulations and guidance, specifically FDA, EMA, and MHRA.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs.  In addition, our best-in-class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, 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.