Senior Associate Global Safety

Amgen; Cambridge; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading biotechnology company in Cambridge is seeking a Senior Associate in Global Safety. In this role, you will ensure regulatory compliance for drug safety activities while collaborating with local and global teams. The ideal candidate will have a life sciences degree and demonstrable experience in pharmacovigilance. This position provides opportunities for professional growth and flexible working arrangements. Join a diverse and inclusive community committed to delivering better healthcare solutions.

Benefits

Flexible working from home options

Generous Total Rewards Plan

Qualifications

• Graduate with life science or healthcare degree and proven relevant industry experience.
• Demonstrable knowledge of processes and regulations in pharmacovigilance.
• Highly motivated, quick to learn and ability to work effectively under own initiative.

Responsibilities

• Ensure adherence to regulatory commitments for pharmacovigilance.
• Perform business critical core safety activities per legal deadlines.
• Support safety risk communications and Risk Management Plans.

Skills

Knowledge of pharmacovigilance regulations

Experience with Safety Databases

Proficient use of MS Office products

Analytical thinking

Attention to detail

Education

Life science or healthcare degree

Job description

Career Category

Safety

Job Description

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 worlds leading biotechnology companies. We are global collaborators who achieve together researching 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.

SENIOR ASSOCIATE GLOBAL SAFETY

LIVE

What you will do

In this vital role you will 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.
• 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.
• Training: Deliver 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.

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).
• Demonstrable knowledge of processes and regulations in pharmacovigilance.
• Experience with Safety Databases.
• 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

• 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.

Application close date : 21st November 2025

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.

Employment Type : Full-Time

Experience : years

Vacancy : 1