Global Safety Director — PASR & Regulatory Strategy

Amgen; England; Sur place; GBP 120 000 - 180 000; Plein temps

Résumé du poste

Amgen seeks a Director Global Safety to lead the Pharmacovigilance Operations responsible for production and submission of periodic aggregate safety reports (PASRs) in alignment with global regulatory requirements and Amgen standards.

You will oversee the PASR lifecycle across the product life cycle, develop strategy for pharmacovigilance operations, and ensure timely delivery of safety reports while maintaining inspection readiness.

Qualifications

• Extensive experience in Drug Safety with knowledge of global pharmacovigilance

Responsabilités

• Provide global leadership for PASR team to ensure regulatory requirements are met
• Develop and maintain Global Periodic Reports Schedule, Standards and Procedures
• Liaise with external vendors, Global Patient Safety and cross-functional teams in PASR creation
• Maintain inspection readiness per PV System Master File
• Be contact for Health Authority Inspection and Internal Process Audits
• Manage Global staff in the functional area

Connaissances

Pharmacovigilance

Global regulatory knowledge

Leadership

Cross-functional teamwork

Stakeholder management

Formation

BS

RPH

RN HCP

Description du poste

Amgen seeks a Director Global Safety to lead the Pharmacovigilance Operations responsible for production and submission of periodic aggregate safety reports (PASRs) in alignment with global regulatory requirements and Amgen standards.

You will oversee the PASR lifecycle across the product life cycle, develop strategy for pharmacovigilance operations, and ensure timely delivery of safety reports while maintaining inspection readiness.