Director Global Safety – Global Periodic Aggregate Safety Reports Director in Cambridge

If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

In this vital role you will be accountable for development of Pharmacovigilance Operations strategy for the production and submission of periodic aggregate safety reports (PASRs) in compliance with global regulatory requirements and Amgen compliance policies and standards. The Global Safety Director is accountable for all aspects of PASRs and periodic reporting processes, schedules, outputs, and metrics throughout the product’s life cycle. You will lead a global team with members in US/EU and Amgen India.

Responsible for participating in cross-functional activities to ensure and promote compliance and consistency with PASR preparation for all Amgen products throughout the life cycle of the product.

• Provide global leadership for PASR team to ensure all regulatory requirements for PASRs are met in the production and submission of all reports.
• Accountable for the development and maintenance of the Global Periodic Reports Schedule, Standards and Procedures.
• Accountable as liaison between external vendors, Global Patient Safety, and cross functional teams (Regulatory Science, Global Clinical Development, Global Biostatistical Sciences, TS&BA, Centre for Observational Research) in the creation of PASRs.
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness.
• Be point of contact for Health Authority Inspection and Internal Process Audits within the remit of the role and responsibility.
• Manage Global staff in functional area.

What we expect of you:

• Degree educated: BS, RPH, RN HCP.
• Extensive experience in Drug Safety with demonstrated knowledge of global aspects of pharmacovigilance.
• Strong knowledge of processes and global regulations for pharmacovigilance and periodic aggregate safety reporting.
• Understanding impact of emerging regulatory requirements and their implications for Amgen.
• Subject matter expertise and technical excellence.
• Experience working on cross-functional teams.
• Strong leadership skills, independence, networking and influencing skills and managerial experience to deal with potential conflict of stakeholders with the ability to bring a diverse group to a common decision.
• Proven leadership skills in execution of goals and processes across global team.
• Able to organize, plan and prioritize workload for the function.
• Ability to effectively manage competing priorities and timelines.
• Excellence in oral and written English.

What you can expect of us:

• Vast opportunities to learn and move up and across our global organization.
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits.

LOCATION: Ability to work fully remote, or, if situated near an office, the option to work flexibly from home with occasional office presence at our Cambridge or Uxbridge next-generation workspace.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.