Global Safety Manager in Uxbridge

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 ensuring adherence to Amgen’s regulatory commitment for pharmacovigilance. You will provide management of a subset of 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: Maintain 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 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 and share with Qualified Person for Pharmacovigilance (QPPV)/Regional Management.
• Periodic 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 for safety risk communications (e.g. Dear Investigator Letter, Urgent Safety Measures, Risk Minimisation Materials etc.) and Risk Management Plans in conjunction with Regulatory Affairs, Clinical and Medical Departments. Maintain awareness of safety profiles of designated Amgen products and new risk information.
• Leadership: Provide management of a subset of safety activities, whilst reporting to the Senior Global Safety Manager. Provide input into cross functional programs, to reflect local requirements or operating environment. Support with process improvement initiatives and implementation of legislative changes. Serve as a safety subject matter expert with the affiliate.
• Deputise: Assist Senior Global Safety Manager / Country Safety Lead with escalation of issues to Regional Management / QPPV, and support with issue resolution. Deputise for Senior Global Safety Manager when necessary.

Be part of our team

You will 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 will 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 will maintain awareness of current prescribing information, safety profile and new risk information for designated Amgen products, to support product safety activities.

What we expect of you

• 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.
• Deep knowledge of processes and regulations in pharmacovigilance.
• Experience with Safety Databases.
• Strong initiative and problem-solving skills.
• 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.

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 occasional office work from our Cambridge next generation workspace.

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.