At a Glance
- Tasks: Lead pharmacovigilance processes and ensure patient safety worldwide.
- Company: Join Amgen, a leading biotechnology company dedicated to serving patients.
- Benefits: Flexible work options, generous rewards, and opportunities for personal growth.
- Other info: Be part of a diverse and inclusive community that values your ideas.
- Why this job: Make a real impact in patient safety while advancing your career.
- Qualifications: Degree in relevant field with experience in pharmacovigilance and team management.
The predicted salary is between 56700 - 69300 £ per year.
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
- Act as US/EU local safety office and FDA/EMA point of contact for safety reporting
- Submission of all individual case safety reports to FDA/EMA, and interactions support with business partners (license partners) and vendors for all case intake and processing activities
- Vendor oversight of all case intake processing activities and case quality including analysis and reporting of trends in quality measures
- Ensure vendor compliance with approved processes and training requirements
- Audit & external inspection support
Be part of our team
You would be joining a global team responsible for the safety oversight of Amgen's combination products, ensuring high-quality, compliant end-to-end case management processes. You will oversee ICSR processing, vendor performance, training, quality and compliance, manage key business partner relationships, support inspections and audits, and help lead case management operations and team activities to ensure global regulatory compliance.
What we expect of you
- Degree educated and direct related experience in PV
- Previous experience directly managing teams, projects, programs or directing the allocation of resources
- Case Processing & Management with a strong preference for experience in combination/devices
- Vendor Management experience including on-boarding and ongoing training support and performance monitoring and metrics distribution
- Understanding of global regulatory requirements for pharmacovigilance
- Experience in supporting inspections or internal audits
- Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook and competence in safety systems
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 regular office work either from our Cambridge or Uxbridge next generation workspace.
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.
Pharmacovigilance Operations Manager in Cambridge employer: Amgen Inc. (IR)
Amgen is an exceptional employer that prioritises a fair and inclusive workplace culture, offering robust support for employee relations across the EMEA region. With a strong commitment to professional development, employees have access to continuous growth opportunities while collaborating with dedicated teams in a dynamic environment. Located in a vibrant area, Amgen provides unique advantages such as a focus on compliance and ethical practices, ensuring that every team member can thrive and contribute meaningfully to the organisation's success.
StudySmarter Expert Advice🤫
We think this is how you could land Pharmacovigilance Operations Manager in Cambridge
✨Unlock Networking Opportunities
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We think you need these skills to ace Pharmacovigilance Operations Manager in Cambridge
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Amgen Inc. (IR)!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Amgen Inc. (IR) that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Amgen Inc. (IR)!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Amgen Inc. (IR), we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Amgen Inc. (IR)
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Amgen Inc. (IR) that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Amgen Inc. (IR)’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
