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- Tasks: Lead GVP quality initiatives and ensure compliance across global pharmaceutical operations.
- Company: Join an innovative pharmaceutical company dedicated to advancing patient safety and regulatory excellence.
- Benefits: Enjoy a full-time role with opportunities for professional growth and a collaborative work environment.
- Why this job: Shape global quality strategies while making a real impact on patient safety and therapeutic development.
- Qualifications: Requires a degree in a scientific field and 8+ years in pharmacovigilance quality roles.
- Other info: This is a senior-level position with a focus on compliance and regulatory engagement.
The predicted salary is between 43200 - 72000 ÂŁ per year.
Singular: Building Brilliant Biotechs provided pay range
This range is provided by Singular: Building Brilliant Biotechs. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
Direct message the job poster from Singular: Building Brilliant Biotechs
Biotech Recruitment Specialist -Principal Talent Executive at Singular: Building Brilliant Biotechs
GVP Quality Safety Specialist
Are you an experienced pharmacovigilance quality professional with a strategic mindset and deep regulatory knowledge? This permanent senior-level GVP Quality Specialist position offers the opportunity to take ownership of global compliance standards and inspection readiness for a leading pharmaceutical organisation.
THE COMPANY
This innovative pharmaceutical company is committed to advancing patient safety through cutting-edge therapeutic development and global regulatory excellence. Operating across international markets, the organisation integrates quality, pharmacovigilance, and medical affairs into a cohesive system built for inspection readiness and long-term sustainability.
As part of a cross-functional quality team, you will play a pivotal role in embedding a robust quality culture while driving forward the organisation’s Good Pharmacovigilance Practice (GVP) framework and global procedural standards.
THE ROLE
In this role, you will take system-level ownership of GVP quality across both internal functions and external partners, overseeing compliance, audit execution, and regulatory engagement. Your remit will span from SOP governance and audit readiness to leading the organisation’s response to evolving regulatory expectations.
You will work closely with Global Medical Affairs, Regulatory Affairs, Clinical Development, and Safety teams to deliver a harmonised approach to GVP quality and pharmacovigilance excellence.
You will focus on Post Market.
KEY RESPONSIBILITIES
- Lead the development, maintenance, and harmonisation of SOPs and quality systems relating to pharmacovigilance.
- Design and oversee execution of GVP audit strategies, including external consultant coordination and CRO/vendor oversight.
- Act as the primary quality representative during regulatory inspections (GVP, DM), ensuring end-to-end readiness across all pharmacovigilance and safety systems.
- Own the development of risk-based quality management plans and proactively identify and mitigate potential compliance gaps.
- Drive implementation and tracking of corrective and preventive actions (CAPAs), following audits and inspections.
ABOUT YOU
You’ll be well suited to this role if you bring:
- A degree in Biology, Pharmacy, Chemistry, or related scientific discipline.
- At least 8 years of experience in pharmacovigilance quality roles within the pharmaceutical or life sciences industry.
- Advanced knowledge of GVP and global regulatory frameworks.
If you\’re ready to take a leading role in shaping GVP quality strategy at a global level, apply now.
Seniority level
-
Seniority level
Mid-Senior level
Employment type
-
Employment type
Full-time
Job function
-
Job function
Science
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Industries
Biotechnology Research and Pharmaceutical Manufacturing
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Quality andSafety Specialist employer: Singular: Building Brilliant Biotechs
Contact Detail:
Singular: Building Brilliant Biotechs Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality andSafety Specialist
✨Tip Number 1
Familiarise yourself with the latest GVP guidelines and regulatory frameworks. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the pharmacovigilance and quality assurance sectors. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the field.
✨Tip Number 3
Prepare to discuss specific examples of how you've implemented quality management plans or handled audits in your previous roles. Real-life scenarios can showcase your expertise and problem-solving skills effectively.
✨Tip Number 4
Research the company’s recent projects and initiatives in pharmacovigilance. Being knowledgeable about their work will allow you to tailor your conversation during interviews and show genuine interest in their mission.
We think you need these skills to ace Quality andSafety Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in pharmacovigilance quality roles. Emphasise your knowledge of GVP and regulatory frameworks, as well as any relevant achievements that demonstrate your strategic mindset.
Craft a Compelling Cover Letter: Write a cover letter that specifically addresses the responsibilities outlined in the job description. Discuss how your background aligns with the company's commitment to patient safety and regulatory excellence.
Showcase Relevant Experience: In your application, provide specific examples of your past work related to SOP governance, audit execution, and compliance management. Use metrics where possible to quantify your impact.
Highlight Soft Skills: Don’t forget to mention your soft skills, such as communication and teamwork. These are crucial for collaborating with cross-functional teams like Global Medical Affairs and Regulatory Affairs.
How to prepare for a job interview at Singular: Building Brilliant Biotechs
✨Showcase Your Regulatory Knowledge
Make sure to highlight your understanding of global regulatory frameworks and Good Pharmacovigilance Practices (GVP). Prepare specific examples from your past experience where you successfully navigated regulatory challenges or improved compliance standards.
✨Demonstrate Strategic Thinking
This role requires a strategic mindset, so be ready to discuss how you've developed and implemented quality management plans. Share instances where your strategic decisions led to significant improvements in quality systems or audit readiness.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world situations. Think about potential compliance gaps you've identified in the past and how you addressed them, as well as your approach to corrective and preventive actions (CAPAs).
✨Emphasise Cross-Functional Collaboration
Since the role involves working closely with various teams, be prepared to discuss your experience in cross-functional collaboration. Highlight how you've effectively communicated and coordinated with different departments to achieve common goals in pharmacovigilance and quality assurance.
