Area Safety Expert

7 days ago


Derrygonnelly Co Fermanagh, United Kingdom CK Group Full time €50,000
Job Title: Area Safety Expert

We are seeking an experienced Area Safety Expert to join our team at CK Group. This role will be based in Issy-les-Moulineaux, with the possibility of working from home 2 days a week.

The successful candidate will have 2-4 years of experience in case data management, reconciliation manager, or vigilance IT project manager roles. Strong IT skills and significant training in case data management are essential for this position.

This is a full-time opportunity with a competitive salary range of approximately €60,000 - €80,000 per year, depending on qualifications and experience. Additional benefits include health insurance, retirement plan, and paid time off.

Key Responsibilities:
• Perform quality checks on PV cases to ensure English translations are accurate.
• Maintain a local tracker of individual safety reports and act as subject matter expert on case management activities.
• Adhere to regulatory timelines for submitting safety reports to local health authorities and communicate potential delays to relevant teams.
• Establish and maintain local indicators on compliance with safety report submissions.
• Support local health authority inspections and audits, including responding to queries and collaborating with the global team to develop CAPA plans.
• Provide PV clauses for inclusion in local agreements and contribute to the PSMF with contract-related information.
• Ensure implementation of local business continuity plans, such as providing Healthcare science professional or equivalent training.

Language Requirements: English and French (verbal and written) at a professional working level.
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