Global Safety Director – Remote Pharmacovigilance Leader

Amgen SA; Greater London; Sur place; GBP 180 000 - 240 000; Plein temps

Résumé du poste

Amgen seeks a Director Global Safety to lead the PASR strategy across the product lifecycle, ensuring global regulatory compliance and quality reporting. You will direct a global team and align PV activities with cross-functional stakeholders to uphold high standards of safety reporting.

You will oversee the PASR process, engage with regulators, vendors, and internal teams, and drive inspection readiness while supporting Amgen’s mission to serve patients.

Qualifications

• Degree educated in a relevant health or science field.
• Extensive experience in Drug Safety with global pharmacovigilance knowledge.
• Strong knowledge of pharmacovigilance processes and PASR reporting.
• Understanding regulatory requirements and their Amgen implications.
• Subject matter expertise and leadership across global teams.

Responsabilités

• Provide global leadership for PASR team to meet regulatory requirements in production and submission of reports.
• Develop and maintain the Global Periodic Reports Schedule, Standards and Procedures.
• Act as liaison between vendors, Global Patient Safety and cross-functional teams in PASR creation.
• Engage in PV System Master File activities and maintain inspection readiness.
• Serve as point of contact for Health Authority Inspections and internal audits.
• Manage Global staff within the function.

Connaissances

Pharmacovigilance

Global leadership

Regulatory compliance

Cross-functional teamwork

English proficiency

Formation

BS, RPH, RN HCP

Description du poste

Amgen seeks a Director Global Safety to lead the PASR strategy across the product lifecycle, ensuring global regulatory compliance and quality reporting. You will direct a global team and align PV activities with cross-functional stakeholders to uphold high standards of safety reporting.

You will oversee the PASR process, engage with regulators, vendors, and internal teams, and drive inspection readiness while supporting Amgen’s mission to serve patients.