Manager,PharmacovigilanceQualityAssurance

**Job Description Summary** The Manager, Pharmacovigilance (PV) QA, provides quality assurance oversight and support of end-to-end PV and Device Vigilance (DV) activities within Novartis to ensure compliance with applicable local and global regulatory requirements and Novartis procedures and quality standards. **Job Description** **Major Accountabilities:** * Support initiatives to maintain or improve quality performance and compliance of Novartis PV activities including case processing, medical safety, risk management, Health Authority reporting, PV IT systems and device vigilance. Champion the quality mindset. * Support initiatives focused on quality, process, and compliance improvement. Through close collaboration with business partners, identify opportunities and develop strategies aimed at simplifying processes and improving quality while ensuring compliance with applicable regulatory requirements. * Provide quality support of transition and integration-related activities for PV and Device Vigilance systems resulting from mergers, acquisitions, and/or divestments. * Support maintenance of the Pharmacovigilance System Master File (PSMF). * Support training initiatives as assigned. * Provide quality support to PS&PV and other groups/business partners involved in PV and DV activities; assist with issue identification and root cause investigations; sign-off investigation reports. * Support Health Authority Inspections, including inspection readiness activities, conduct, and follow-up. * Guide the development of robust and sustainable corrective and preventative action plans (CAPA) in collaboration with the responsible groups performing PV and DV activities. Monitor status of corrective and preventative actions to ensure the issues are adequately addressed, completed, and appropriately documented. * Ensure quality and regulatory compliance issues are promptly communicated to appropriate management. Support initiatives geared towards remediation of compliance concern