Senior Director, Pharmacovigilance QA

 Leads and optimizes Sunovion’s Global PVQA function that supports Sunovion regional and DSP global products in compliance with ICH Guidelines and international regulatory requirements.
• Develops and maintains PVQA policies and procedures, and provides input and QA oversight for policies and procedures applicable to the broader Pharmacovigilance System.
• Conducts or leads Quality Assurance activities for compliance issue investigations, deviations, training and CAPA.
• In collaboration with quality counterparts globally establishes and executes a global risk-based PV audit program for DSP Companies, contract vendors and third parties working closely.
• Leads inspection readiness and management activities for Sunovion and coordinates global inspection readiness activities for PV inspections of global products.
• Collaborates with global PVRM and quality staff as well as QPPV to ensure global coordination of quality system activities.
• Monitors the global and regional PV Quality System through metrics and reports on the status of the Quality Systems through the Quality Governance structure.