Patient Safety Leader

3 days ago


Dublin, Dublin City, Ireland beBeeExpert Full time $180,400 - $300,700
Job Summary

The Director, Patient Safety Intake and Regulatory Submissions plays a pivotal role in ensuring the safety and integrity of products.

Key Responsibilities:
  • Oversight of patient safety intake and regulatory submissions processes to guarantee compliance with global regulations and contractual obligations.
  • Liaise with health authorities, Alliance Partners, and internal stakeholders to foster collaborative relationships and drive business success.
  • Develop and maintain best practices for high-quality and compliant point-of-contact activities, leveraging expert knowledge of tools and systems for data automation, advanced data validation, and analytics.
  • Manage vendors and oversee database configuration and assessment of study particulars, ensuring seamless integration and efficient operations.
  • Review and creation of metrics to measure intake and reporting compliance, driving continuous improvement and excellence.
  • Train and mentor staff on safety information and intake submission processes, promoting knowledge sharing and skill development.
  • Serve as subject matter expert for audits and inspections, providing authoritative guidance and support.
Requirements:
  • Bachelor's Degree in life sciences or clinical research, or a licensed healthcare professional, required for this position.
  • Minimum 12 years of experience in safety and safety reporting, demonstrating expertise and leadership skills.
  • Excellent knowledge of Argus and its applications, essential for success in this role.
  • Strong written and verbal communication skills, critical for effective collaboration and stakeholder engagement.
  • Ability to work independently and prioritize effectively in a matrix team environment, managing multiple tasks and deadlines.
About Us:

Our organization values diversity and inclusion, providing comprehensive benefits and opportunities for growth and development. We are an equal opportunity employer, welcoming applicants from diverse backgrounds.



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