Associate Director - GPS Standards & Training
November 12
Description
• developing and maintaining the PV Quality Management System in collaboration with subject matter authorities • coordinating the assignment of adverse event (AE) & product complaint (PC) training globally to vendors • creating a training program for all individuals within the GPS and relevant personnel involved in GVP • regularly reviewing all procedures to ensure they accurately reflect the GPS activities being followed • monitoring compliance with required training and addressing non-compliance by working with line management • leading or participating in initiatives to continuously improve the effectiveness and efficiency of GPS processes • maintaining the AE-PC contract language and liaising with Legal, Procurement, and Commercial as needed to support contract review/update
Requirements
• at least 7+ years of experience in Pharmacovigilance/Drug Safety, Regulatory Affairs, or Quality Assurance within the pharmaceutical/biotech industry • A Bachelor's degree is required • previous extensive knowledge and experience within Pharmacovigilance/Drug Safety regulations and PV Quality Management Systems • a consistent record of successful project management related to quality management
Benefits
• health and wellness programs • fitness centers • equity awards • annual bonuses • paid time off
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