Clinical Safety Specialist

7 days ago


Dubai, Dubai, United Arab Emirates InterSystems Full time
Job Description

**Clinical Safety Specialist**

We are seeking a highly skilled Clinical Safety Specialist to join our team at InterSystems. As a key member of our organization, you will be responsible for providing clinical safety assurance services across our products.

Key Responsibilities:
  • **Clinical Safety Assurance**: Provide clinical safety assurance services across InterSystems' products, ensuring compliance with regulatory requirements and industry standards.
  • **Framework Development**: Adapt and refine InterSystems' Clinical Safety Management Framework and Plan for use, ensuring it meets the evolving needs of our products and customers.
  • **Escalation Point**: Act as the escalation point for reported clinical safety issues, providing timely and effective resolution.
  • **Safety Reporting**: Create Safety Reports as appropriate from issues reported by Customers, Implementation and Support staff, ensuring accurate and comprehensive documentation.
  • **Clinical Safety Assessments**: Perform clinical safety assessments to assist internal teams (Regional Edition, Implementation and Support), identifying potential risks and opportunities for improvement.
  • **Training and Development**: Deliver clinical safety training to internal and external groups, ensuring knowledge sharing and best practices.
  • **Clinical Safety Group**: Participate in the Clinical Safety Group activities, contributing to the development of clinical safety strategies and initiatives.
  • **Documentation**: Create and maintain Region, Project, and clinical safety documentation, ensuring accuracy and compliance.
  • **Customer Support**: Provide clinical safety/risk assessment advice at customer sites, ensuring effective support and guidance.
  • **Lessons Learned**: Provide advice and bring experience to the customer and ISC team in terms of lessons learned in the field, particularly around clinical safety.
Requirements:
  • **Clinical Background**: Possess a clinical background, with a strong understanding of clinical safety principles and practices.
  • **Professional Registrations**: Hold relevant professional registrations, demonstrating expertise and commitment to the field.
  • **Stakeholder Engagement**: Proven clinical stakeholder engagement, negotiation, and influencing skills, ensuring effective collaboration and communication.
  • **Problem-Solving**: Excellent problem-solving and analytical skills, identifying and resolving complex clinical safety issues.
  • **Communication**: Excellent communication and presentation skills, ensuring clear and concise communication of clinical safety information.
  • **Language Skills**: Excellent written and spoken English, with the ability to communicate effectively with diverse stakeholders.


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