• Develops, implements, and maintains quality management systems for drug safety and pharmacovigilance activities, including SOPs, guidelines, controlled documentation, and training programs. • Oversees pharmacovigilance compliance activities, including audits, inspections, deviation management, CAPA (Corrective and Preventive Actions), and root cause analyses. • Advises on pharmacovigilance quality, ensuring adherence to global regulations (FDA, EMA, ICH, GVP, MHRA) and industry standards. • Defines, tracks, and reports key metrics and performance indices to measure the effectiveness of pharmacovigilance quality programs and training. • Monitors and analyzes safety data to identify trends, potential risks, and areas for improvement; leads risk management and mitigation strategies. • Designs and implements comprehensive training strategies for pharmacovigilance staff, cross-functional teams, and vendors, ensuring ongoing compliance and competency. • Leads preparation for regulatory inspections and audits. • Acts as the main point of contact for QA during audits, including response formulation. • Leads corrective action plans related to drug safety and quality assurance. • Identifies gaps in pharmacovigilance systems/processes and drives continuous improvement initiatives. • Collaborates with internal and external stakeholders, including clinical, regulatory, and quality teams, to ensure integrated safety processes and documentation. • Stays current with evolving global regulations and best practices in drug safety and quality management. • Manages and mentors drug safety and quality staff; fosters a culture of continuous improvement and compliance. • Collaborates with Safety Systems to manage and implement change control procedures.