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    Cambridge / Uxbridge
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    Drug Safety And Pharmacovigilance
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    Salary: £22,000 per annum

2024-2025 Industrial Placements - Amgen

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focusses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen supports access to medicines in low and middle income countries, environmental sustainability, responsible sourcing, ethical research, science education, charity gift matching and volunteering. In the UK, a mental health support and wellbeing programme has won MIND Workplace Wellbeing Gold Award for the second year running.

Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2023 Amgen was honoured as a Best Workplace in Europe, an award based on employee’s perception of workplace and organisation’s culture.

We are offering two industrial placement roles:

1 x Clinical Trial Operational Quality role, based in Uxbridge, UK

1 x Local Safety Officer and Pharmacovigilance Operations role, based in Cambridge, UK

Clinical Trial Operational Quality Placement Student - Uxbridge

Based in our Uxbridge office, with some opportunity to work from home, our Operational Quality Placement Student will rotate through three teams in the group: Clinical Trial Risk Management (CTRM), Inspection Readiness (IR) and Trial Master File Operations (TMF Ops). All three teams work across clinical development phases I-IV and trial designs to ensure the governing ICH GCP clinical trial regulations are met fully.

CTRM focuses on leading, managing and mitigating risks in clinical trials, inspection readiness employs various strategies and tools to maintain a clinical trial in a regulatory health authority inspection prepared state, and TMF Ops owns the strategy, requirements, and system for Amgen clinical trial records.

The successful candidate will gain invaluable experience in clinical trial development, risk management and critical documentation requirements by providing support, engaging, and maintaining collaborative relationships with vendors and customers, both in and outside of Amgen

Local Safety Officer and Pharmacovigilance Placement Student - Cambridge

The Local Safety Officer and Pharmacovigilance Placement Student will be based in our Cambridge office, with some opportunity to work from home .

Drug safety (also known as pharmacovigilance) is the science and activities relating to detection, assessment, understanding and prevention of side effects (known as adverse events) of medicines. This allows an understanding of both the risks as well as the benefits of a medicine.

The local safety officer is responsible for representing patient safety in interactions with Government Authorities in the United Kingdom and Ireland, external healthcare professionals and internal departments to ensure compliant performance of drug safety activities based on legislative requirements.

In this role you will gain experience in:

  • Adverse event data collection, processing and reporting to Government Authorities and Ethics Committees for medicines in clinical trials and on the market.
  • Liaison with healthcare professionals in writing, to collate complete safety and clinical data on adverse event reports.
  • Providing quality and timely responses to internal and external drug safety questions.
  • Providing drug safety advice to internal departments for local activities, to advance the safe use of medicines and support business needs.
  • Participation in local Medical and Commercial meetings to discuss product safety issues.

In both roles, the successful students will gain:

  • Experience of working in a busy global department within the pharmaceutical industry
  • An excellent opportunity to understand the drug development process
  • Industry exposure to working to ICH GCP clinical trial regulations/ local safety regulations for the UK and Ireland and European Union
  • Insight into many departments within Amgen
  • Experience of working in exemplary multi-disciplinary teams

All applicants should have:

  • Excellent exam and course work grades from the first year of your Life Sciences degree as listed (or higher qualification). Biology, Biochemistry, Microbiology, Biological Sciences, Biomedical Engineering, Medicinal Chemistry, Pharmacology, or modular degrees in Human Sciences and Life Sciences or medical-related degrees (e.g. nursing, medical students, physicians associates).
  • Good communication and organisational skills
  • A self-motivated, proven professional and proactive approach to work
  • An ability to work in teams and remain flexible to changing priorities
  • A genuine interest in the healthcare/pharmaceutical industry and a willingness to learn new areas and skills
  • An awareness of global regulatory requirements and ICH guidelines for conducting clinical research and safety monitoring/reporting (eg, Good Clinical Practice (GCP), Good Pharmacovigilance Practices(GVP)
  • Please note, this role is for Life Sciences Undergraduates only, studying a subject as listed above.

Please ensure that you are willing and able to live within commutable distance of the specified company location before applying.

The Clinical Trial Operational Quality role is based in Uxbridge, and the Local Safety Officer and Pharmacovigilance Operations role is based in Cambridge.

Amgen is a value-based organisation, committed to promoting and maintaining an inclusive, high-performing culture where all team members embrace and leverage each other’s talents and backgrounds. Amgen’s goal is to foster a culture of belonging, where diverse talent is widely represented, and everyone feels welcome. Closing date for applications: 07/01/2024 at 23:59 Notification of application outcome: 15/01/2024 Industry introduction and interviews: 17th – 19th January 2024. Interviews will be held in person at the Amgen office in Uxbridge , and may be preceded by an initial phone call.

Start date: 1st July 2024, for 12 months with a potential extension.

Salary: £22,000 per annum

Please note that Hays are managing the recruitment for this placement.

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