Pharmacovigilance Operations Manager

Career Category

Job Description

If you feel like youre part of something bigger its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching manufacturing and delivering ever-better products that reach over 10 million patients worldwide. Its 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 Amgens 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 Amgens 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.

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 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

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.

APPLY NOW

Objects in your future are closer than they appear. Join us.

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.