Director Global Safety – Global Periodic Aggregate Safety Reports Director
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What you'll do
- 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 they're looking for
- 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
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Career Category
SafetyJob Description
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.
DIRECTOR GLOBAL SAFETY – Global Periodic Aggregate Safety Reports Director
What you will do
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.
Key Responsibilities:
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
WIN
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:
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
THRIVE
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
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.
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Equal Opportunity Statement
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.
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