At a Glance
- Tasks: Oversee quality of pharmacovigilance vendors and ensure compliance with regulations.
- Company: Join CSL Seqirus, a leading global influenza vaccine provider.
- Benefits: Competitive salary, health benefits, and a commitment to inclusion.
- Other info: Dynamic work environment with opportunities for professional growth.
- Why this job: Make a real impact on patient safety and global health.
- Qualifications: 3+ years in GVP or PV quality, strong communication skills.
The predicted salary is between 60000 - 80000 £ per year.
Patient safety depends on more than what happens inside a company's walls. Much of the critical work in pharmacovigilance case processing, literature monitoring, signal management, and medical information is carried out by external partners. When that network of vendors operates to the highest quality standards, the system works. When it doesn't, the consequences are real.
This role exists to make sure it works.
Why this role matters
PV quality oversight is often invisible when it's done well and very visible when it isn't. As the internal authority on GVP vendor quality, you will be the person others turn to when the questions are difficult. If you take quality seriously, understand the regulatory landscape deeply, and want to shape how a global company manages its external PV network, this is a role with real scope to make a difference.
What you will do
- This role owns the quality oversight of CSL's pharmacovigilance vendors and service providers, including safety and PV CROs, ICSR and case processing providers, literature monitoring, signal management, medical information, and call centre providers.
- You will lead the end-to-end PV vendor lifecycle: defining qualification and risk-based oversight strategy, owning quality agreements, overseeing CAPAs, and driving issue management and continuous improvement, ensuring adherence to GVP, data integrity, and applicable PV regulations.
- You will be the senior quality point of contact for PV vendor matters, partnering with and influencing relevant stakeholders.
- Define and own the risk-based qualification and requalification strategy for PV vendors, and own the negotiation and maintenance of Quality Agreements.
- Establish vendor KPIs, SLAs, dashboards and governance forums, and lead periodic reviews to hold vendors accountable and ensure CAPAs are implemented, verified, and effective.
- Lead PV inspection readiness for vendor-related scope, including front and back room support and storyboard development.
- Set the quality standards expected of PV vendors against GVP, ICH, GVP Modules and ALCOA+; own the QMS procedures, templates and training governing PV vendor oversight; and provide input to deviation, complaint, change control and CAPA processes.
- Lead risk assessments, set controls and monitoring frequency based on risk, and analyse trends across audit findings, deviations and complaints to inform management reviews.
- Maintain expert knowledge of GVP regulations and PV industry trends, and act as the internal reference point.
What you will bring
- 3+ years of GVP or PV quality experience, including direct pharmacovigilance vendor or service-provider oversight.
- Track record of owning quality agreements and contributing to a vendor oversight programme.
- Working knowledge of audit and inspection management processes. You will not conduct audits, but you will need to assess audit findings, review CAPA adequacy and own effectiveness checks.
- Demonstrated knowledge of GVP Modules, EU pharmacovigilance legislation, ICH guidance and ALCOA+ data integrity principles.
- Strong communication, influencing and negotiation skills at stakeholder and vendor level.
- Ability to work autonomously.
- Bachelor's degree in a relevant scientific discipline; postgraduate qualification desirable.
GVP Vendor Oversight and QA Lead (EU) in Reading employer: CSL Behring
CSL Seqirus is an exceptional employer that prioritises patient safety and quality in pharmacovigilance, offering a dynamic work environment where your expertise can truly make a difference. With a strong commitment to inclusion and belonging, employees benefit from a culture that fosters innovation and collaboration, alongside opportunities for professional growth and development. Located in the heart of Europe, this role not only provides a chance to influence global health outcomes but also offers competitive benefits and a supportive workplace that values diversity and employee well-being.
StudySmarter Expert Advice🤫
We think this is how you could land GVP Vendor Oversight and QA Lead (EU) in Reading
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those who work at CSL or similar companies. A friendly chat can open doors and give you insights that might just land you an interview.
✨Tip Number 2
Prepare for the interview by diving deep into GVP regulations and the latest trends in pharmacovigilance. Show us you’re not just familiar with the basics but are genuinely passionate about quality oversight.
✨Tip Number 3
Practice your communication skills! You’ll need to influence stakeholders and negotiate with vendors, so being clear and confident in your delivery is key. Try mock interviews with friends or use online platforms.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining our team at CSL.
We think you need these skills to ace GVP Vendor Oversight and QA Lead (EU) in Reading
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your experience in GVP and PV quality oversight. We want to see how your skills align with the specific requirements of the role, so don’t hold back on showcasing your relevant achievements!
Showcase Your Knowledge:Demonstrate your understanding of GVP regulations and pharmacovigilance processes in your application. We’re looking for candidates who can speak the language of the industry, so include any relevant certifications or training that back up your expertise.
Be Clear and Concise:When writing your application, keep it straightforward and to the point. We appreciate clarity, so avoid jargon and ensure your key points stand out. This will help us quickly see why you’re a great fit for the role!
Apply Through Our Website:We encourage you to submit your application through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the details you need about the role and our company there!
How to prepare for a job interview at CSL Behring
✨Know Your GVP Inside Out
Make sure you brush up on your knowledge of Good Pharmacovigilance Practices (GVP) and the relevant EU regulations. Being able to discuss these topics confidently will show that you’re serious about quality oversight and understand the regulatory landscape.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific vendor-related challenges. Think of examples from your past experience where you successfully managed vendor relationships or resolved quality issues, and be ready to share those stories.
✨Showcase Your Communication Skills
Since this role involves influencing stakeholders and vendors, practice articulating your thoughts clearly and persuasively. You might want to prepare a few key points on how you’ve effectively communicated complex information in previous roles.
✨Demonstrate Continuous Improvement Mindset
Be prepared to discuss how you’ve contributed to continuous improvement initiatives in your past roles. Highlight any experience you have with CAPAs and how you’ve driven effective changes based on audit findings or vendor performance.
