Director Global Safety- Global Periodic Aggregate Safety Reports

Amgen•Thousand Oaks, CA

About The Position

The Director Global Safety – Global Periodic Aggregate Safety Reports is accountable for developing Pharmacovigilance Operations strategy for the production and submission of periodic aggregate safety reports (PASRs), in accordance with global regulatory requirements and Amgen compliance policies and standards. The role oversees PASR activities and periodic reporting processes, schedules, outputs, and metrics throughout the product life cycle. The Director leads a global team with members in the US, EU, and Amgen India, and participates in cross-functional activities to promote compliance and consistency in PASR preparation for Amgen products. The role also undertakes activities delegated by the QPPV, maintains inspection readiness, serves as a point of contact for relevant Health Authority inspections and internal process audits, and manages staff in the functional area.

Requirements

Doctorate degree and 4 years of Global Safety experience, or a master’s degree and 8 years of Global Safety experience, or a bachelor’s degree and 10 years of Global Safety experience.
At least 4 years of experience directly managing people and/or leadership experience leading teams, projects, or programs, or directing the allocation of resources.

Responsibilities

Provide global leadership for the PASR team to ensure all regulatory requirements are met in the production and submission of reports.
Develop and maintain the Global Periodic Reports Schedule, standards, and procedures.
Serve as liaison among external vendors, Global Patient Safety, and cross-functional teams in the creation of PASRs.
Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain inspection readiness.
Serve as a point of contact for Health Authority inspections and internal process audits within the remit of the role.
Manage global staff in the functional area.
Participate in cross-functional activities to ensure and promote compliance and consistency in PASR preparation for Amgen products throughout their life cycle.