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 and belonging.
- Other info: Dynamic work environment with opportunities for professional growth.
- Why this job: Make a real impact on patient safety and shape global vendor management.
- Qualifications: 3+ years in GVP or PV quality, strong communication skills, and a relevant degree.
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, 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 Maidenhead employer: CSL Seqirus
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 are encouraged to grow and innovate while enjoying comprehensive benefits and a culture that values diversity. Located in the heart of Europe, this role provides unique opportunities to influence global health outcomes and collaborate with leading professionals in the industry.
StudySmarter Expert Advice🤫
We think this is how you could land GVP Vendor Oversight and QA Lead (EU) in Maidenhead
✨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 know your stuff and can talk confidently about how you’d handle vendor oversight.
✨Tip Number 3
Practice your communication skills! You’ll need to influence stakeholders and negotiate quality agreements, so role-play with a friend or use online resources to sharpen those skills.
✨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 Maidenhead
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your experience in GVP and vendor 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 pharmacovigilance regulations and quality standards in your application. We’re looking for someone who knows their stuff, so include any relevant certifications or training that can set you apart from the crowd.
Be Clear and Concise:When writing your application, keep it straightforward and to the point. We appreciate clarity, so avoid jargon and make sure 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 for us to receive your details and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at CSL Seqirus
✨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 to be asked how you would handle specific vendor-related challenges. Think of examples from your past experience where you successfully managed quality agreements or CAPAs, and be ready to explain your thought process and the outcomes.
✨Showcase Your Communication Skills
This role requires strong communication and influencing skills. Prepare to demonstrate how you've effectively communicated with stakeholders and vendors in the past. Use examples that highlight your negotiation skills and ability to build relationships.
✨Understand the Vendor Lifecycle
Familiarise yourself with the end-to-end vendor lifecycle in pharmacovigilance. Be ready to discuss how you would define qualification strategies, set KPIs, and ensure compliance with quality standards. This will show that you can take ownership of the vendor oversight process.
