Director, Global Safety – Global Periodic Aggregate Safety Reports

This is a fully remote position, open to applicants in United States.

📋 Description

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

• Manage all facets of PASRs and the periodic reporting processes, timelines, outputs, and metrics throughout the product lifecycle.

• Lead a global team comprising members from the US/EU and Amgen India.

• Engage in cross-functional initiatives to ensure compliance and uniformity in PASR preparation for all Amgen products.

• Provide global leadership for the PASR team, ensuring adherence to regulatory requirements.

• Create and uphold the Global Periodic Reports Schedule, Standards, and Procedures.

• Act as a liaison among external vendors, Global Patient Safety, and cross-functional teams in the development of PASRs.

• Execute tasks assigned by the QPPV as outlined in the PV System Master File.

• Ensure inspection readiness at all times.

• Act as the primary contact for Health Authority Inspections and Internal Process Audits.

• Oversee global staff within the functional area.

⛳️ Requirements

• Doctorate degree with 4 years of Global Safety experience, OR Master’s degree with 8 years of Global Safety experience, OR Bachelor’s degree with 10 years of Global Safety experience.

• Minimum of 4 years of experience in directly managing personnel and/or demonstrated leadership in guiding teams, projects, programs, or resource allocation.

• Proven experience in Pharmacovigilance Operations and periodic aggregate safety reports (PASRs).

• Familiarity with global regulatory requirements and compliance policies and standards.

• Capability to maintain inspection readiness.

• Sponsorship for this position is not guaranteed.

🏝️ Benefits

• A comprehensive employee benefits package, which includes 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 feasible.

• Opportunities for career development.

• Financial plans that provide opportunities to save for retirement or other objectives.

• Work/life balance.

• Reasonable accommodations for applicants and employees with disabilities.