Director, Global Safety – Global Periodic Aggregate Safety Reports

Amgen

. Develop Pharmacovigilance Operations strategy for the production and submission of periodic aggregate safety reports (PASRs) .

Posted 10/27/2026full-timeRemote • United StatesLead💰 $191,067 - $258,503 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Pharmacovigilance Operations, including the development and oversight of Periodic Aggregate Safety Reports (PASRs) while ensuring compliance with global regulatory requirements. Proven leadership in managing cross-functional teams and maintaining inspection readiness.

Highest-signal resume keywords

Pharmacovigilance OperationsPeriodic Aggregate Safety Reports (PASRs)Global Regulatory RequirementsLeadership ExperienceInspection Readiness

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Pharmacovigilance OperationsPeriodic Aggregate Safety Reports (PASRs)Global Regulatory RequirementsCompliance PoliciesInspection ReadinessProject ManagementResource AllocationMetrics DevelopmentStandards and Procedures DevelopmentCross-Functional Collaboration

Soft Skills

LeadershipTeam ManagementCommunicationCollaborationProblem-Solving

Industry Keywords

Global SafetyHealth Authority InspectionsInternal Process AuditsQPPVPV System Master File

About the role

Key responsibilities & impact

Develop Pharmacovigilance Operations strategy for the production and submission of periodic aggregate safety reports (PASRs)
Oversee all aspects of PASRs and periodic reporting processes, schedules, outputs, and metrics throughout the product life cycle
Lead a global team with members in the US/EU and Amgen India
Participate in cross-functional activities to ensure compliance and consistency with PASR preparation for all Amgen products
Provide global leadership for the PASR team and ensure regulatory requirements are met
Develop and maintain the Global Periodic Reports Schedule, Standards and Procedures
Liaise between external vendors, Global Patient Safety, and cross-functional teams in creating PASRs
Undertake activities delegated by the QPPV as detailed in the PV System Master File
Maintain inspection readiness
Serve as point of contact for Health Authority Inspections and Internal Process Audits
Manage global staff in the functional area

Requirements

What you’ll need

Doctorate degree and 4 years of Global Safety experience, OR Master’s degree and 8 years of Global Safety experience, OR 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, programs, or directing the allocation of resources
Experience in Pharmacovigilance Operations and periodic aggregate safety reports (PASRs)
Knowledge of global regulatory requirements and compliance policies and standards
Ability to maintain inspection readiness
Sponsorship for this role is not guaranteed

Benefits

Comp & perks

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible
Career development opportunities
Financial plans with opportunities to save towards retirement or other goals
Work/life balance
Reasonable accommodations for applicants and employees with disabilities