Area Safety Compliance Specialist

3 weeks ago


Derrygonnelly, Fermanagh and Omagh, United Kingdom CK Group Full time
Safety Officer Role Overview

Location: Issy-les-Moulineaux, France

Duration: 12 months

Estimated Salary: €50,000 per annum

This role involves ensuring the submission of high-quality safety reports to local health authorities while adhering to regulatory timelines. Additionally, you will be responsible for maintaining local trackers and collaborating with the global team to develop corrective action plans as necessary.

Main duties include:

  • Quality checking PV cases and ensuring accurate English translations.
  • Maintaining local safety report trackers and acting as a subject matter expert on case management activities.
  • Communicating potential delays in safety report submissions to relevant teams.
Key Responsibilities:
  • Developing and implementing local indicators for safety report compliance.
  • Participating in local health authority inspections and audits, providing responses to queries, and collaborating with the global team on CAPA plans.
  • Providing PV clauses for local agreements and contributing to the PSMF with relevant contract information.
Requirements:
  • Healthcare science professional or equivalent qualification.
  • Strong background in case data management with excellent IT skills.
  • Minimum 2 years of relevant experience in case data management, reconciliation management, or vigilance IT project management.
Language Skills:

Proficient in English and French (verbal and written) at a professional working level.



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