Senior Safety Specialist
1 week ago
CK Group is seeking a skilled Senior Safety Specialist to join their team in Issy-les-Moulineaux, France. This 12-month contract offers a salary of €50,000 per year.
Main Responsibilities:- Quality Assurance and Translation Verification: Conduct thorough checks on PV cases to ensure accurate English translations.
- Safety Report Tracking and Expertise: Maintain up-to-date records of individual safety reports and serve as the subject matter expert on case management activities at the local level.
- Timely Reporting and Communication: Adhere to regulatory timelines for submitting safety reports to local health authorities and communicate any potential delays to relevant teams.
- Local Compliance Indicators: Establish indicators for the compliance of safety report submissions.
- Health Authority Inspections and Audits: Support inspections and audits, including responding to queries and collaborating with the global team to develop CAPA plans.
- Contractual Provisions and PSMF: Provide PV clauses for inclusion in local agreements and contribute to the PSMF with contracts-related information.
- Business Continuity Planning: Ensure implementation of local business continuity plans, such as emergency preparedness and response procedures.
- Professional Qualifications: Healthcare science professional or equivalent training.
- Case Data Management Skills: Significant training in case data management with strong IT skills.
- Relevant Experience: 2-4 years of relevant experience, such as case data management, reconciliation manager, or vigilance IT project manager.
Proficiency in English and French is required, both verbally and in writing, at a professional working level.
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Area Safety Compliance Specialist
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Global Safety Compliance Specialist
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Risk Management Specialist
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Safety Compliance Specialist CK Group
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