Global Patient Safety Quality Manager (Pharmacovigilance)

About the role

The Global Patient Safety (GPS) Quality Management Manager runs the operational execution of the Pharmacovigilance (PV) Quality Management System within the Global Patient Safety function, in a standard office setting Monday to Friday. The role contributes to growing the GPS Quality Management function and reports to the Associate Director, GPS Quality Management or above.

Key responsibilities

• Audit and inspection: support and manage GVP audit and inspection activities, prepare the GPS team for inspections, ensure inspection documents are ready, and help coordinate responses to audit findings
• Deviation and CAPA: assess issue management trends, identify internal deviations, support root cause analysis and the implementation of corrective and preventive actions with the client Quality function
• Training and procedures: develop, maintain and deliver the PV training program, update curricula, train clients and third parties, and manage procedural documents using the Veeva system
• Performance and compliance: develop and evaluate KPIs, monitor compliance with third-party contractual obligations and PVAs, liaise with the QA department, and monitor SOPs and other controlled documents

Required profile

• Bachelor's degree in pharmacy, nursing, healthcare or another life science or technical field, or an equivalent combination of education and experience
• At least 5 years in the pharmaceutical or biotech industry, with at least 3 years in pharmacovigilance or drug safety
• Track record of running PV quality systems, processes and teams
• Experience preparing for, hosting and responding to audits and regulatory inspections globally
• Knowledge of PV regulatory requirements (Europe, US, Japan) and GXP quality and compliance requirements

Required skills

• Fluent written and spoken English
• Proficiency with Microsoft Office and tracking databases
• Ability to author procedural documents and work independently in a global environment