Amgen
Pharmacovigilance Operations Manager
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Career Category
Safety
Job 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.
PHARMACOVIGILANCE OPERATIONS MANAGER
LIVE
What you will do
In this vital role you will serve patients worldwide by executing Amgen’s pharmacovigilance processes.
- Act as US/EU local safety office and FDA/EMA point of contact for safety reporting
- Submission of all individual case safety reports to FDA/EMA, and interactions support with business partners (license partners) and vendors for all case intake and processing activities
- Vendor oversight of all case intake processing activities and case quality including analysis and reporting of trends in quality measures
- Ensure vendor compliance with approved processes and training requirements
- Audit & external inspection support
Be part of our team
You would be joining a global team responsible for the safety oversight of Amgen's combination products, ensuring high-quality, compliant end-to-end case management processes. You will oversee ICSR processing, vendor performance, training, quality and compliance, manage key business partner relationships, support inspections and audits, and help lead case management operations and team activities to ensure global regulatory compliance.
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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 and direct related experience in PV
- Previous experience directly managing teams, projects, programs or directing the allocation of resources
- Case Processing & Management with a strong preference for experience in combination/devices
- Vendor Management experience including on-boarding and ongoing training support and performance monitoring and metrics distribution
- Understanding of global regulatory requirements for pharmacovigilance
- Experience in supporting inspections or internal audits
- Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook and competence in safety systems
THRIVE
What you can expect of us
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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 flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.
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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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