Safety Aggregate Report Coordinator Associate

Poland - Warsawonsitejunior

Posted today · via Workday

About this role

Position Purpose Individual filling the position are responsible for the project management of safety aggregate reports submitted to regulators that include the FDA and EMA. The incumbent will partner with various colleagues from safety, clinical, regulatory and other functional lines to produce the aggregate reports and ensure that these reports are completed in a timely manner meeting regulatory compliance. Primary Responsibilities Lead report preparation from prep to submission with key stakeholders/contributors within Clinical, Regulatory, Safety, DevOps, Submissions, etc. Review data to ensure consistency between various contributors. Compile the information for reports using various electronic tools and document management system.…

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2

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3

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4

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5

Location fit

This role is based in Poland - Warsaw. We weight your proximity and willingness to relocate.

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