Your new company
Are you an experienced Pharmacovigilance professional looking to make a significant impact within a global, research-driven pharmaceutical organisation?
We are partnering with a leading international biopharmaceutical company to recruit a Senior Pharmacovigilance Safety Data Transformation Lead / Specialist within the Patient Safety Operations - Data Transformation team on a 12-month contract basis.
Within this team, you will use our 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 - having the biggest impact on patient safety.
Hybrid - 2 days Welwyn Garden City
OUTSIDE IR35
Ltd / Um - Up to £48 p/h
PAYE - Up to £35.82 p/h
Your new role: Key responsibilities include:
- Performing oversight of service provider who executes 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
We are keen to hear from experienced Pharmacovigilance professionals with a strong background in Pharmacovigilance within the pharmaceutical, biotechnology, or CRO sector.
You will ideally possess:
- Significant pharmacovigilance and drug safety experience.
- Demonstrated experience in a breadth of areas pertaining to 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).
- Desirable: Medical Device processing experience, knowledge.
- Evidence of leading complex, time-pressured projects, working with a wide range of stakeholders.
- Evidence of proactive, self-driven, independent working
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 residing in the UK.
This is a fantastic opportunity to join a world-class organisation at the forefront of healthcare innovation, working on cutting-edge therapies and contributing directly to patient safety on a global scale.