Global Regulatory Affairs and Safety Operations Manager (AW) Job Listing at Sunrise Systems Inc in Thousand Oaks, CA
Our major pharmaceutical client is looking for Global Regulatory Affairs & Safety Operations Manager in Thousand Oaks, CA.
To support execution of organized data collection plans, studies and protocols, while supporting local requirements, through the provision of safety elements within protocols/study plans and related documents, any other organized venue that may provide adverse event data.
? To support overall safety surveillance of products.
? To serve as the case management liaison for ensuring product specific requirements are met.
? Provide technical and operational support to ensure Safety Operations objectives are incorporated into studies and other activities/efforts that may provide adverse event data.
? Support and/or manage other staff in functional area.
? Provide study team and case management support for cross-functional activities.
? Provide internal audit & external inspection support to Safety Operations and other functions.
? Represent safety operations as the product lead in Global Clinical Study Teams and Global Safety Teams for products.
? Oversee and support Identification of literature cases.
? Provide input to the development of safety standards and language within study-related documents.
? Contribute to ensuring inspection readiness.
? Monitor safety database workflow for potential product issue escalation.
? Support product launch plans and publication needs.
? Operationally author and manage/maintain the core product.
? Provide review/QC of safety data in study and product documents for regulatory submission.
? Provide study team and Safety Operations support for reconciliation, /synchronization of study data against safety data.
? Perform antibody re-testing coordination (non-LAO tasks for repeat testing)
? Provide treatment assignments to Case Processing group for single case unblinding for regulatory reporting.
? Contribute to management and oversight of CROs with safety reporting responsibilities.
? Contribute on safety data conventions and processes, as well as interdeparmental processes.
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