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Global Risk Management Plan Manager
hace 2 meses
The Global Risk Management Plan Manager provides critical support to the medical safety physicians in the management, coordination, development, reviewing, and tracking of Safety Risk Management Plans to ensure that documents are of high quality, regulatory compliant, and that logistics and distribution are handled in an appropriate and timely manner.
This role involves initiating the tracking of commitments and liaising with relevant functions that maintain and monitor the commitments.
The Global Risk Management Plan Manager will support the Global Product Safety Leader (GPSL) and the designated medical writer for the timely preparation, development, and finalization of high-quality and regulatory-compliant safety Risk Management Plans (RMP).
This includes supporting the GPSL/GPT to resolve issues as they arise regarding the RMP strategy, RMP preparation, RMP implementation, and RMP overall process.
The Global Risk Management Plan Manager will guide the GPSL and key authors to ensure that commitments are appropriately worded and reviewed by all relevant line functions and comments incorporated into the final document.
This role involves coordinating activities from the different line units to ensure all documents required to support the RMP main document are included in the RMP annexes and available in the Document Management System according to Novartis processes.
The Global Risk Management Plan Manager will manage all logistical aspects related to the timely development of the safety RMP annexes and work with authors of the different line functions to ensure RMP annexes content meets Novartis and Health Authorities (HA) requirements.
This role involves supporting the Safety Lead in updating the RMP according to HA requirements and ensuring they are aligned with Periodic Safety Update Report (PSUR)/Periodic Benefit Risk Evaluation Report (PBRER).
The Global Risk Management Plan Manager will review the RMP to ensure consistency and regulatory compliance of RMP sections and annexes.
This role involves tracking HA feedback and assessment on RMP and ensuring HA requirements are implemented as required (e.g., in individual RMP, in global RMP template).
The Global Risk Management Plan Manager will ensure timely submission and delivery of high-quality RMPs to Health Authorities.
This role involves ensuring RMP document and annexes are fully compliant with Novartis and Health Authorities technical and format requirements.
All documents required to support the RMP main document are included in the RMP annexes and available in the Document Management System according to Novartis processes.
The Global Risk Management Plan Manager will ensure distribution of RMP CoSTA commitments to affiliates and HQ GPT is performed within 15 working days of Health Authority approval.
A database of Health Authorities feedback on RMP is kept up to date.
