.-Monitors and audits the company's drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance and assessment against product labeling. Reports events or reactions as required by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports. May provide trending and safety signal detection and assessment. Supports all clinical trial activity and post marketing.About the Role The 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 the preparation of action plans for PS&PV leadership endorsement. Ensure oversight of management of Patient Safety Quality Issues and Quality Events in AQWA/1QEM.Your key responsibilities, but not limited to; Through oversight and trending of the below areas; Receipt of Quality Issues and Quality EventsEntry in to AQWA/1 QEMTimely completion of investigationsImplementation of appropriate CAPAs and availability of appropriate evidenceCompletion of effectiveness checksTimely closure in AQWA,/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 Quality Issue & Quality Event process.Monitor compliance of the Patient Safety organization to Quality Issue & Quality Event handling processes and standards and where deficiencies are identified, develop and implement strategies to address these.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 CMO&PS organization.Collaborate with other Global Line Functions across Novartis Divisions and Third Parties to establish and meet joint accountabilitiesLead 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 to global regulatory requirementsAct 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
