Job Description

Career Category Safety



HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you\xe2\x80\x99re part of something bigger, it\xe2\x80\x99s because you are. At Amgen our shared mission\xe2\x80\x94to serve patients\xe2\x80\x94drives all that we do. It is key to our becoming one of the world\xe2\x80\x99s leading biotechnology companies. We are global collaborators who achieve together\xe2\x80\x94researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It\xe2\x80\x99s 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\xe2\x80\x99s 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 with a focus on the safety oversight of Amgen\xe2\x80\x99s combination products/end-to-end processing.

• Support ICSR processing to ensure high quality cases in a timely manner to meet all worldwide regulatory authority requirements
• Provide vendors with resources and training to perform their role
• Support the analysis and communication of case QC results and escalation of any case processes issues
• Lead development and delivery of training materials for case management conventions
• Management of multiple business partner relationships for case management
• Support reviews of contract wording for case related data exchange
• Monitoring compliance in regard to regulatory submissions and/or contractual wording for data exchange
• Assign tasks within Case Management to direct and indirect reports
• Support management of staff within Case Management
• Audit & external inspection support, including being the point of contact for Health Authority Inspection and maintaining a state of inspection readiness

LOCATION: Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.

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:

• Master\xe2\x80\x99s degree, Bachelors degree or Associates degree are preferred with directly 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

As we work to develop treatments that take care of others, so we work to care for our teammates\xe2\x80\x99 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

APPLY NOW

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. 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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Amgen