Sr. Manager Pharmacovigilance (PV) QMS and Compliance (Remote)

Position: The role will ensure compliance with global pharmacovigilance regulations and guidelines, lead the development and implementation of pharmacovigilance Quality Management System (QMS), manage PV audits and inspections, vendor oversight/KPIs, and oversee training programs to enhance the pharmacovigilance system. This role is critical in maintaining the highest standards of drug safety, regulatory compliance, and continuous improvement.

Responsibilities:

• Develop, implement, and maintain the pharmacovigilance quality management to ensure consistent quality and compliance
• Develop and maintain pharmacovigilance policies and procedures in alignment with regulatory requirements
• Monitor changes in pharmacovigilance regulations and assess their impact on company processes
• Monitor vendor’s key performance indicators (KPIs) to ensure quality and standards
• Support safety database integration and data migration
• Serve as the PV compliance subject matter expert for internal audits, FDA, and global regulatory inspections
• In collaboration with Quality Assurance team, define and implement PV CAPAs as applicable and ensure assessment of root cause and effective improvement plans
• Develop and implement comprehensive training programs for PV staff to ensure knowledge of regulatory requirements, QMS, and company procedures
• Identify areas for process improvement within the PV system and lead initiatives to enhance efficiency and compliance
• Support global business expansion activities and ensure inspection readiness for FDA and EMA submissions
• Supports the creation and maintenance of internal and external PV-related training, including training matrices and compliance records for the pharmacovigilance department; ensure training materials are current and effective   
• Lead the development of the EU Pharmacovigilance System Master File (PSMF) including maintenance of periodic updates, as applicable

Qualifications:

• Bachelor's degree in life science, nursing, pharmacy, or related field; advanced degree preferred
• Minimum 5 years’ experience in pharmacovigilance, with strong focus on pharmacovigilance quality and compliance
• In-depth knowledge of global pharmacovigilance regulations and guidelines (FDA, EMA, MHRA, etc.,) is required
• Knowledge of adverse event reporting and processing in a clinical trial and post marketing setting is required
• Experience in PV quality systems, compliance monitoring, development and maintenance of standards and processes
• Proven experience in managing audits and regulatory inspections
• Experience with safety database implementation and data migration
• Excellent communication and interpersonal skills, with the ability to work effectively in a cross-functional team environment
• Experience leading and contributing to process improvements, QMS initiatives, inspection readiness, Health Authority audits, standardization of safety reports, SDEA/PVA/SMP, vendor management, etc.,
• Ability to effectively communicate, collaborate, and deliver excellent work in a fast-paced, and rapidly growing department and organization
• Ability to work independently with minimal supervision

Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix.  By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy (https://www.nurixtx.com/privacy-policy/).