Senior Director, Pharmacovigilance QA

Location
Marlborough, MA
Posted
Dec 14, 2018
Discipline
Science/R&D
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time

 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.

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