.SummaryLead activities and initiatives designed to identify and categorize risks that potentially impact the Vigilance system and the broader CMO&PS organization as well as prepare action plans for CMO&PS leadership endorsement. Ensure oversight of management of Patient Safety deviations and quality incidents in AQWA/1QEM.About the RoleThe Senior Risk Management Manager leads activities and initiatives designed to identify and categorize risks that potentially impact the Vigilance system and the broader PS&PV organization as well as prepare action plans for PS&PV leadership endorsement. Ensure oversight of management of Patient Safety deviations and quality incidents in 1QEM.Your Key Responsibilities:Through oversight and trending of the following areas:Receipt of deviations and incidentsEntry into 1QEMTimely completion of investigationsImplementation of appropriate CAPAs and availability of appropriate evidenceCompletion of effectiveness checksTimely closure in 1QEMDrive the development of actionable insights and mitigation plans to ensure that any opportunities for improvement are identified and acted upon as early as possible.Lead and support strategic projects related to Risk Management of the Novartis Vigilance System.Prepare/maintain guidance documents and training material to educate Patient Safety associates on the deviation and quality incident process.Monitor compliance of the Patient Safety organization to deviation and quality incident handling processes and standards and develop and implement strategies to address deficiencies.Collaborate with the Compliance, Process Excellence, QPPV Office, and other functions to produce metrics and complete trend analyses designed to identify areas of risk with impact on the Vigilance System and/or PS&PV organization.Collaborate with other Global Line Functions across Novartis Divisions and Third Parties to establish and meet joint accountabilities.Lead the development and maintenance of respective procedural documents including ownership of relevant PSMF sections and annexes.Support the review of emerging worldwide regulations, performing impact assessments, and driving process changes required to ensure ongoing compliance with global regulatory requirements.Support the execution and monitoring of global self-assessments within PS&PV.Act as a subject matter expert during audits and inspections, lead the preparation of responses to findings and the development and implementation of corrective and preventative actions.Prepare reports and/or presentations to document the outcome of risk assessments for the Governance & Risk management team and escalate key findings to the Head Governance & Risk and/or relevant governance or LT board.Support the management of the Operational Metrics & Risk Committee as the Secretary; scheduling the meetings, preparing the agenda, and tracking and following up on actions
