Your newpany
My client, a global biopharmaceuticalpany 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 City12 Month + ContractOutside IR35PAYE - £33 – p/hLtd / Umbrella - £45 - 50 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,pliant manner, so it can be used to understand andmunicate the product benefit risk to protect patients’ safety.
1. Performing oversight of service providers who execute ICSR tasks and Medical Device reports
2. Answering queries and proactive sharing of your subject matter expertise to stakeholders
3. Conducting process reviews to design and implement process improvements
4. Identifying root causes of nonpliance to agree Corrective Actions and Preventative Actions (CAPAs), which you may be responsible for implementing
5. 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 themercial environment) and of rapidly evolving personalised healthcare environment and ecosystem.- Medical Device processing experience/knowledge.- Evidence of leadingplex, time-pressured projects, working with a wide range of stakeholders.