Job Description
Primary Job Function
The Safety Documentation Specialist is primarily responsible for document management, formatting and archiving of periodic reports and medical safety documents (e.g. Health Hazard Assessments, signal evaluation reports) and ensures accurate distribution of all Medical Safety Documents to internal stakeholders, Affiliates and License Partners.
Core Job Responsibilities
Distributes Medical Safety DocumentsAccurately processes (including eCTD formatting), distributes and archives periodic safety reports and Risk Management Plans of the Periodic Reporting and Medical Writing Group per department procedures within specified timeframes to ensure compliance with global safety regulations and best practices.Acts as GPV Business Administrator for the DARIUS Document Management System.Manages GPV specific documents in DARIUS and has an oversight on GPV documents and their archive location.Sets up, main...
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