Description

You will lead the strategy, development, and execution of the pharmacovigilance quality management system, ensuring patient safety and compliance with global regulations. This role involves oversight of quality, training, documentation, audits, and inspections, fostering a culture of safety and continuous improvement.

Requirements

• Expert knowledge of global PV regulations (GCP, GVP)
• Strategic thinking and ability to influence cross-functional teams
• Experience in organizing and overseeing pharmacovigilance quality and compliance
• Vendor management skills
• Leadership and organizational skills

Responsibilities

• Co-develop and implement global PV-QMS strategy
• Develop and implement PV training strategy
• Lead, mentor, and coach GPS staff in compliance
• Oversee budget and vendor management for PV CROs
• Ensure inspection readiness and manage global inspections