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Amgen Manager, PV Operations Commercial & Study Liaison in Cambridge, United Kingdom

Manager, PV Operations Commercial & Study Liaison


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


What you will do

In this vital role, you will be responsible for the development and execution of Pharmacovigilance Operations strategy for safety-related organized data collection in Amgen clinical trials and commercial activities in compliance with global regulatory requirements and Amgen compliance policies and standards.

You will also be participating in cross-functional activities to ensure and promote compliance, with pharmacovigilance data collection standards and operational consistency across clinical trials and commercial programs for all Amgen products.

Key responsibilities

  • Work on projects and process that ensures the strategies of the department are executed into the safety related organized data collection activities in Amgen clinical trials and commercial activities to ensure Amgen remains compliant with global safety legislation and requirements

  • Provide knowledge into Clinical and Commercial teams on the needs and timelines of safety related organized data collection to ensure these needs are met and incorporated into Amgen studies and commercial activities/programs

  • Accountable as liaison between clinical trial and commercial programs (patient support and market research) and Global Patient Safety to ensure capture of all adverse event data generated by such programs and activities

  • Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness

  • Participate in the creation and dissemination of appropriate safety reporting language in commercial and clinical trial key documents

  • Support activities to ensure PV Operations input to commercial initiatives

  • Actively participates in cross functional projects that develop and support strong cross-functional relationships and communication

  • Maintain knowledge of adverse event reporting process and safety system and contribute to the development, improvement and standardization of new processes and methods

  • Contribute to projects which involve the implementation of new processes and methods within and across Global Patient Safety

  • Maintain functional area standard operating procedures and contribute to R&D Standards documents as applicable

  • Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness

  • Act as a representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility


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 in a relevant discipline, with proven experience within Pharmaceutical or Biotechnology

  • Strong communication skills, with the ability to le to effectively represent ideas both verbally and in writing

  • Extensive knowledge of the global safety environment, regulations and guidance, including compliance issues and/or scientific discovery

  • Project and/or Process Management experience & knowledge

  • Experience and knowledge of safety data capture, representation and interpretation

  • Ability to work cross-functionally within matrix environment

  • Strong organisation planning and prioritising workload

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

  • Flexible working from home and remote options available within the UK


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.

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, 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.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney diseases, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.