At a Glance
- Tasks: Ensure safety compliance and manage pharmacovigilance activities for Amgen products.
- Company: Join Amgen, a leading biotechnology company dedicated to serving patients worldwide.
- Benefits: Flexible work options, generous rewards, and opportunities for personal and professional growth.
- Other info: Be part of a diverse community that values your unique contributions.
- Why this job: Make a real impact in patient safety while collaborating with global teams.
- Qualifications: Life science degree and experience in pharmacovigilance required.
The predicted salary is between 36000 - 60000 € per year.
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.
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.
- Maintain own current knowledge of and compliance with local safety regulations.
- 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.
- Handle 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.
- Assist with submission of DSUR and PSUR safety reports to Regulators and Ethics Committees where applicable.
- Support for safety risk communications and Risk Management Plans in conjunction with Regulatory Affairs, Clinical and Medical Departments.
- 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.
- 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.
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
- 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.
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.
Global Safety Manager in Cambridge employer: Amgen
At Amgen, we pride ourselves on being a leading biotechnology company that prioritises the well-being and professional growth of our employees. Our inclusive work culture fosters collaboration and innovation, allowing you to contribute meaningfully to patient care while enjoying flexible working arrangements from our state-of-the-art Cambridge office. With a generous Total Rewards Plan and vast opportunities for career advancement, Amgen is an exceptional employer for those seeking a fulfilling and impactful career in safety management.
StudySmarter Expert Advice🤫
We think this is how you could land Global Safety Manager in Cambridge
✨Tip Number 1
Network like a pro! Reach out to current or former employees at Amgen on LinkedIn. A friendly chat can give you insider info and maybe even a referral, which can really boost your chances.
✨Tip Number 2
Prepare for the interview by knowing your stuff! Brush up on pharmacovigilance regulations and be ready to discuss how your experience aligns with Amgen's mission. Show them you’re not just another candidate!
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or use online platforms. The more comfortable you are talking about your skills and experiences, the better you'll perform when it counts.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re genuinely interested in being part of the Amgen team.
We think you need these skills to ace Global Safety Manager in Cambridge
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that align with the Global Safety Manager role. Highlight your knowledge of pharmacovigilance regulations and any relevant industry experience to catch our eye!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about safety in the biotech field and how your background makes you a perfect fit for our team at Amgen.
Showcase Your Team Spirit:We love team players! In your application, mention examples of how you've collaborated with others in past roles. This will show us that you can work well with our diverse and inclusive community.
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re serious about joining our mission to serve patients.
How to prepare for a job interview at Amgen
✨Know Your Pharmacovigilance Regulations
Make sure you brush up on the latest pharmacovigilance regulations relevant to the UK and Ireland. Being able to discuss these confidently will show that you're not just familiar with the basics, but that you’re committed to compliance and safety.
✨Showcase Your Case Management Skills
Prepare specific examples of your experience with case management and how you've handled adverse event reports in the past. Highlighting your ability to meet legal deadlines and manage critical safety activities will demonstrate your readiness for this role.
✨Demonstrate Team Collaboration
Since this role involves working closely with local and global colleagues, be ready to share examples of how you've successfully collaborated in a team setting. Emphasise your natural team player qualities and how you relate well to people at all levels.
✨Be Ready for Problem-Solving Scenarios
Expect to face hypothetical scenarios during the interview that test your problem-solving skills. Prepare to discuss how you approach challenges methodically and your attention to detail, as these are crucial in ensuring patient safety.
