My client, a global biopharmaceutical company with a goal of contributing to healthcare innovation and environmental sustainability and which is focused on improving people's quality of life, specialising in Oncology, neurology and rare diseases, and has a position available for a Senior Pharmacovigilance Scientist - Safety Data and ICSR Professional to join their Patient Safety Operations team on a 12-month initial contract.
Hybrid - 2 days Welwyn Garden City
12 Month + Contract
Outside IR35
Ltd / Umbrella - £45 - 50 p/h
PAYE - £33 - 37.76 p/h
Your new role
As the Senior Pharmacovigilance Scientist - Safety Data and ICSR professional, you will use your pharmacovigilance expertise, particularly individual case safety report (ICSR) knowledge, to ensure safety data is processed and reported in a high quality, compliant manner, so it can be used to understand and communicate the product benefit risk to protect patients' safety.
Performing oversight of service providers who execute ICSR tasks and Medical Device reports
Answering queries and proactive sharing of your subject matter expertise to stakeholders
Conducting process reviews to design and implement process improvements
Identifying root causes of non-compliance to agree Corrective Actions and Preventative Actions (CAPAs), which you may be responsible for implementing
Impact assessment of new / updated regulatory requirements
What you'll need to succeed
In order to apply for the Senior Pharmacovigilance Scientist - Safety Data and ICSR role, you must possess:
-Expert experience in pharmacovigilance, and pharmacovigilance legislation; good knowledge of international regulations (ICH, EU GVP Modules, FDA) and an understanding of the pharmaceutical industry (product development and the commercial environment) and of rapidly evolving personalised healthcare environment and ecosystem.
- Medical Device processing experience/knowledge.
- Evidence of leading complex, time-pressured projects, working with a wide range of stakeholders.
What you need to do now
Before you apply for this position, it is vital that you are in possession of a UK passport or relevant visa to work without restrictions in the UK and must be based in the UK.
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call Roberta Atkins on (phone number removed)
Salary description
£33.00 - £50.00 per hour