Sn Pharmacovigilance Scientist - Safety Data & ICSR
Posted 5 days ago by Hays
£50 Per hour
Outside
Hybrid
Welwyn Garden City, England, United Kingdom
Summary: The Senior Pharmacovigilance Scientist - Safety Data and ICSR Professional will join a global biopharmaceutical company focused on healthcare innovation and environmental sustainability. This role involves ensuring high-quality processing and reporting of safety data, particularly individual case safety reports (ICSRs), to protect patient safety. The position is a 12-month contract based in Welwyn Garden City, requiring expertise in pharmacovigilance and regulatory compliance. The role is hybrid, allowing for two days of on-site work per week.
Key Responsibilities:
- Ensure safety data is processed and reported in a compliant manner.
- Perform oversight of service providers executing ICSR tasks and Medical Device reports.
- Answer queries and share subject matter expertise with stakeholders.
- Conduct process reviews to design and implement improvements.
- Identify root causes of non-compliance and agree on Corrective Actions and Preventative Actions (CAPAs).
- Assess the impact of new or updated regulatory requirements.
Key Skills:
- Expert experience in pharmacovigilance and legislation.
- Good knowledge of international regulations (ICH, EU GVP Modules, FDA).
- Understanding of the pharmaceutical industry and personalised healthcare ecosystem.
- Medical Device processing experience/knowledge.
- Evidence of leading complex, time-pressured projects.
Salary (Rate): £50.00/hr
City: Welwyn Garden City
Country: United Kingdom
Working Arrangements: hybrid
IR35 Status: outside IR35
Seniority Level: Senior
Industry: Other
Your new company 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 03330106292
Desired Skills and Experience Pharmacovigilance