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Amgen Senior Associate Global Safety in Cambridge, United Kingdom

HOW MIGHT YOU DEFY IMAGINATION?

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.

SENIOR ASSOCIATE GLOBAL SAFETY

LIVE

What you will do

In this vital role you be responsible for ensuring adherence to Amgen’s regulatory commitment for pharmacovigilance. You will perform a wide variety of drug safety activities within the UK and Ireland affiliate, working with both local and global colleagues, and based on sound knowledge of pharmacovigilance regulations and company procedures.

  • Pharmacovigilance Legislation: Maintains own current knowledge of and compliance with local safety regulations.

  • Case management: Perform business critical “core” safety activities per legal deadlines including intake of AE reports, follow up with HCPs for complete data, ICSR & aggregate safety report submission to regulators. Handling safety enquiries received to the departmental inbox from both internal and external stakeholders. Review metrics to monitor MHRA & HPRA submission compliance.

  • P eriodic Reporting: Assist with submission of DSUR and PSUR safety reports to Regulators and Ethics Committees where applicable. Perform review of relevant PSUR safety signals for MHRA notification.

  • Risk Management: Support with distribution of safety risk communications (e.g. Dear Investigator Letter, Urgent Safety Measures, Risk Minimisation Materials etc) in conjunction with Regulatory Affairs, Clinical and Medical Departments.

  • Training : Delivers safety reporting training for local affiliate staff and external service providers.

  • Key contact: Serves as key contact for defined safety activities within the affiliate. Provides expert safety input into various cross-functional initiatives e.g. Patient Support Programs, Market Research, Digital Media Projects, local Study Protocols etc, to ensure compliance while understanding local business needs.

Be part of our team

You would be joining the UK & Ireland Safety Team, based in the local affiliate, and collaborating with other affiliate functions and also with Global Patient Safety colleagues, to meet business needs. Together with team members, you would conduct business critical safety tasks, provide support to audits and inspections, and assist the Senior Global Safety Manager with activities and issue resolution where necessary. Within the team, you would maintain awareness of safety profiles and new risk information for designated Amgen products, to support product safety activities.

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:

  • Graduate with life science or healthcare degree and proven relevant industry experience within post market and clinical trial pharmacovigilance.

  • Use of MS Office products to a proficient standard – Word, Excel, PowerPoint.

  • Demonstrable knowledge of processes and regulations in pharmacovigilance.

  • Experience with Safety Databases, particularly ARGUS, would be desirable.

  • Natural team player with the personal qualities to relate well to people at all levels.

  • Aptitude for analytical thinking, with a methodical approach and unquestionable attention to detail.

  • Highly motivated, quick to learn, with ability to work effectively under own initiative and a strong drive for excellence.

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

  • Flexible working from home options available

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.

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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.

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 disease, 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.

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