Global Regulatory Affairs and Safety Operations Manager (AW) Job Listing at Sunrise Systems Inc in Thousand Oaks, CA

Staffing/Employment

Our major pharmaceutical client is looking for Global Regulatory Affairs & Safety Operations Manager in Thousand Oaks, CA.

Job Description

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.

Job Responsibilities

? 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.