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...for both clinical and post-marketing projects to the Safety Submissions team if contracted to submit the reports.
Participate in audits/inspections as required.
Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor...
...training sessions according to the project specific requirements.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Maintains a working knowledge of ICH...