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For Companies At a Glance
- Tasks: Lead safety assessments and collaborate on innovative drug development projects.
- Company: Join Amgen, a pioneering biotech company dedicated to improving patient lives.
- Benefits: Flexible work options, generous rewards, and opportunities for personal growth.
- Why this job: Make a real impact in healthcare while advancing your career in a supportive environment.
- Qualifications: Degree in relevant field and experience in clinical research or biotech.
- Other info: Be part of a diverse team that values collaboration and innovation.
The predicted salary is between 36000 - 60000 £ per year.
Overview
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
PHARMACOVIGILANCE SCIENTIST MANAGER
What you will do
In this vital role the Global PV Scientist Manager works with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations. This person will also provide scientific and compliance expertise as needed to GPS.
- Contribute to the planning, preparation, writing and review of non-medical portions of aggregate reports
- Work with affiliates and other internal Amgen partners regarding deliverables
- Review of AE/SAEs from clinical trials as needed
- Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents
- Review standard design of tables, figures, and listings for safety data from clinical studies
- Participate in development of safety-related data collection forms for clinical studies
- Attend study team meetings as requested or needed
- Conduct signal detection, evaluation, and management
- Perform data analysis to evaluate safety signals and write up analysis results in collaboration with GSO
- Prepare safety assessment reports and other safety documents and regulatory responses
- Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
- Participates in Safety Governance per Amgen processes
- Prepare presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making body
- Assist GSOs and other Senior Scientists in the development of risk management strategy and activities
- Provide contents for risk management plans
- Update strategy and content for regional risk management plans
- Assist GSOs to coordinate risk minimization activities including tracking of activities as needed
- Evaluate risk minimization activity
- Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO
- Support activities related to new drug applications and other regulatory filings
- Assist GSO/ or other Senior Scientist in developing a strategy for safety-related regulatory activities
- Provide safety contents for filings
- Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
- Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a strong collaborator with these qualifications.
- Degree educated with directly relevant Global Patient Safety experience
- Clinical/medical research experience
- Experience in a biotech/pharmaceutical setting
- Strong technical competency
- Strong attention to detail and time management
- Strong written communication
- Strong planning and problem solving skills
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. Fully remote setting may be considered
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
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.
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Pharmacovigilance Scientist Manager employer: Amgen
Contact Detail:
Amgen Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Pharmacovigilance Scientist Manager
✨Network Like a Pro
Get out there and connect with people in the industry! Attend conferences, webinars, or local meetups related to pharmacovigilance. You never know who might have the inside scoop on job openings or can refer you directly to hiring managers.
✨Ace the Interview
Prepare for your interviews by researching Amgen’s values and recent projects. Be ready to discuss how your experience aligns with their mission to serve patients. Practice common interview questions and think of examples that showcase your skills in safety assessment and collaboration.
✨Showcase Your Expertise
During interviews, don’t just talk about your past roles—highlight specific achievements in pharmacovigilance. Use data and results to back up your claims. This will demonstrate your strong technical competency and attention to detail, which are crucial for the role.
✨Apply Through Our Website
Make sure to apply directly through Amgen's careers page. This not only shows your interest but also ensures your application is seen by the right people. Plus, it’s a great way to stay updated on new opportunities that match your skills!
We think you need these skills to ace Pharmacovigilance Scientist Manager
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Pharmacovigilance Scientist Manager role. Highlight your relevant experience in Global Patient Safety and any specific projects that align with Amgen's mission.
Showcase Your Skills: Emphasise your strong written communication skills and attention to detail. Use examples from your past work to demonstrate how you've successfully managed safety assessments or contributed to clinical studies.
Be Authentic: Let your personality shine through in your application. We want to see your passion for the biotech field and how you can contribute to our collaborative culture at Amgen.
Apply Through Our Website: Don’t forget to submit your application through our careers page! It’s the best way to ensure it gets into the right hands and shows your enthusiasm for joining the Amgen team.
How to prepare for a job interview at Amgen
✨Know Your Stuff
Make sure you brush up on your pharmacovigilance knowledge and the specific therapeutic areas Amgen focuses on. Be ready to discuss safety assessment activities and how your experience aligns with their mission to serve patients.
✨Showcase Your Collaboration Skills
Amgen values strong collaboration, so prepare examples of how you've worked effectively in teams. Highlight any experiences where you contributed to safety assessments or worked with cross-functional teams to solve problems.
✨Be Detail-Oriented
Given the importance of attention to detail in this role, be prepared to discuss how you ensure accuracy in your work. Bring examples of how you've managed complex data analysis or prepared safety documents in previous positions.
✨Prepare for Regulatory Questions
Since the role involves regulatory inquiries and risk management plans, review common regulatory processes and be ready to discuss your experience with them. This will show that you understand the compliance aspect of the role and can contribute effectively.