Associate Director in GPS Standards & Training
We are seeking an experienced professional to maintain the Pharmacovigilance (PV) Quality Management System. This critical role ensures compliance with regulatory PV requirements worldwide and operates efficiently, aligning with established industry practices.
Daily Responsibilities:
• Develop and maintain the PV Quality Management System in collaboration with subject matter authorities.
• Coordinate global assignment of adverse event (AE) & product complaint (PC) training to vendors.
• Create a training program for all individuals within the GPS and relevant personnel involved in GVP.
• Regularly review procedures to ensure they accurately reflect GPS activities.
• Monitor compliance with required training and address non-compliance by working with line management.
• Lead or participate in initiatives to improve GPS processes' effectiveness and efficiency.
• Maintain AE-PC contract language and liaise with Legal, Procurement, and Commercial as needed.
Requirements:
• 7+ years of experience in Pharmacovigilance/Drug Safety, Regulatory Affairs, or Quality Assurance within the pharmaceutical/biotech industry.
• Bachelor's degree required.
• Extensive knowledge and experience within Pharmacovigilance/Drug Safety regulations and PV Quality Management Systems.
• Successful project management related to quality management is essential.
About Regeneron:
Regeneron is an equal opportunity employer that values diversity and inclusion. We offer comprehensive benefits, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off.