Responsible for the drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post-marketing programs. Participates in the resolution of any legal liability and complying with governmental regulations. Provides and contributes trending and safety signal detection and risk management assessment for the products' life cycle. Provides safety support to the clinical development teams.
About the Role The Global Risk Management Plan Manager provides 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.
Initiates the tracking of commitments and liaises with relevant functions that maintain and monitor the commitments. Supports 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).
Supports the GPSL/GPT to resolve issues as they arise regarding the RMP strategy, RMP preparation, RMP implementation and RMP overall process. Guides the GPSL and key authors to ensure that commitments are appropriately worded and reviewed by all relevant line functions and comments incorporated into final document.
Coordinates 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. Manages all logistical aspects related to the timely development of the safety RMP annexes and works with authors of the different line functions to ensure RMP annexes content meets Novartis and Health Authorities (HA) requirements.
Supports the Safety Lead in updating the RMP according to HA requirements and ensures they are aligned with Periodic Safety Update Report (PSUR)/ Periodic Benefit Risk Evaluation Report (PBRER). Reviews the RMP to ensure consistency and regulatory compliance of RMP sections and annexes.
Tracks HA feedback and assessment on RMP and ensures HA requirements are implemented as required (e.g., in individual RMP, in global RMP template). Ensures timely submission and delivery of high quality RMPs to Health Authorities. Ensures RMP document and annexes are fully compliant with Novartis and Health Authorities technical and format requirements. Ensures 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.
Ensures distribution of RMP CoSTA commitments to affiliates and HQ GPT is performed within 15 working days of Health Authority approval. Keeps database of Health Authorities feedback on RMP up to date.
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