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Director of Pharmacovigilance Safety Systems

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About the role

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Director of Pharmacovigilance Safety Systems
 
ICON currently has an exciting opportunity for a Director to join the Global Pharmacovigilance & Safety Services division to be ideally based in the UK or Europe and reporting directly to the Vice President of Pharmacovigilance and Regulatory Services. This new and exciting opportunity is part of our continuing commitment in growing and enhancing automation of our Global Pharmacovigilance and Safety Reporting groups.
 
As the Director of Safety systems you will offer your technical proficiency combined with PV expertise to ensure that safety systems within Pharmacovigilance Services enable streamlined processes and run efficiently and accurately. The role requires extensive ARGUS knowledge, prior experience of migrating safety data and thorough understanding of implications to recent changes to regulatory requirements for example E2BR3, as well as the understanding of contractual obligations to clients.
 
 
The role
 
  • Reports to the Vice President of Pharmacovigilance and Regulatory Services
  • Provides technical consultation or support services for PV projects and process owners on all system activities
  • Business Lead of Safety System throughout the entire life cycle including development, maintenance, troubleshooting and upgrades
  • Ensures all safety system activities are completed in accordance with SOPs, SSPs, WPs and other applicable regulations. Establish new SOPs, SSPs, WPs if needed.
  • Provides safety database technical expertise in internal and external meetings as needed
  • Contributes to ICON’s PV Roadmap for System Development
  • Works with the wider team to understand the PV landscape, requirements, processes and technology to drive clarity and understanding and to provide reliable and high quality business-driven results.
  • Responsible as System / Database Owner for technical support, maintenance and continued development / implementation of systems and tools for internal and clients.
 
 
Requirements
  • Extensive expertise in ARGUS with an understanding of CSV
  • Experience in the implementation of systems, particularly safety databases
  • Broad understanding of regulatory requirements from a Drug Safety perspective
  • Experience in maintaining, implementing and upgrading PV systems
  • Knowledge of PV and regulatory compliance
  • Solid experience with GxP validation
  • Previous experience of migration of safety data (experience with migration of multi-tenant environment is a plus)
  • Experience and knowledge of Pharmacovigilance processes
  • Knowledge of regulatory safety submissions
  • Experience of working in a global environment 
Benefits of working at ICON
Other than working with a great team of people, we offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
 
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
 
What’s next?
 
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
 
 
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