Director, Global Safety – Global Periodic Aggregate Safety Reports

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

📋 Description

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

• Oversee all facets of PASRs and the periodic reporting processes, including schedules, outputs, and metrics throughout the product life cycle.

• Direct a global team with members located in the US, EU, and Amgen India.

• Engage in cross-functional activities to guarantee compliance and uniformity in PASR preparation.

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

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

• Collaborate with external vendors, Global Patient Safety, and cross-functional teams to develop PASRs.

• Execute tasks assigned by the QPPV and ensure readiness for inspections.

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

• Supervise global personnel within the functional area.

⛳️ Requirements

• Bachelor’s degree in a relevant field: BS, RPH, RN HCP.

• Significant experience in Drug Safety with proven knowledge of global pharmacovigilance aspects.

• Strong understanding of processes and international regulations related to pharmacovigilance and periodic aggregate safety reporting.

• Familiarity with emerging regulatory requirements and their implications.

• Expertise in the subject matter and technical proficiency.

• Experience in cross-functional team collaborations.

• Exceptional leadership, independence, networking, influencing, and managerial abilities.

• Demonstrated leadership capabilities in achieving goals and processes across a global team.

• Competence in organizing, planning, and prioritizing work tasks.

• Ability to efficiently manage competing priorities and timelines.

• Proficiency in oral and written English.

🏝️ Benefits

• Extensive opportunities for learning and advancement within the global organization.

• A diverse and inclusive community fostering a sense of belonging.

• A comprehensive Total Rewards Plan that includes health, finance, and wealth benefits, work/life balance, and career development opportunities.

• Option for fully remote work, or flexible home working with occasional office presence near Cambridge or Uxbridge.