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- Tasks: Conduct audits to ensure drug safety compliance and improve operational resilience.
- Company: Join a leading global pharmaceutical company committed to quality and safety.
- Benefits: Competitive salary, travel opportunities, and a chance to make a real impact.
- Other info: Dynamic role with opportunities for professional growth and development.
- Why this job: Be part of a vital team ensuring drug safety and regulatory compliance.
- Qualifications: Degree in biological science or pharmacy; experience in quality assurance and auditing.
The predicted salary is between 50000 - 65000 £ per year.
Quality in a globalized drug safety network is a matter of operational resilience as much as regulatory mandate. This role serves as a PV Auditor within our Research & Development Quality audit program, responsible for executing the global audit plan to ensure the accuracy of safety data and compliance with legal and corporate standards. By conducting audits of our external partners and internal safety functions, you identify the findings and non‑compliance trends that could impact the reliability of our pharmacovigilance system. We are looking for an experienced auditor who can navigate complex safety environments and work collaboratively with stakeholders to develop corrective actions that ensure long‑term systemic stability.
Main Responsibilities
- Audit Execution: Conduct assigned external audits of pharmacovigilance vendors and service providers, as well as internal self‑inspections of safety processes, procedures, and Local/Regional Safety Officers (LSO/RSOs).
- Reporting & Risk Categorization: Develop and issue comprehensive Audit Reports, categorizing findings by risk level and providing recommendations for corrective and preventive actions (CAPA) related to drug safety and signal management.
- Trend Analysis: Identify non‑compliance trends and systematic risks within the PV discipline, communicating these findings to line management and functional leads to protect the integrity of the Pharmacovigilance System Master File (PSMF).
- Continuous Improvement: Support initiatives to improve standard operating procedures (SOPs) for audit conduct and partner with stakeholders to develop risk‑based, compliant solutions for safety reporting and data handling.
- Regulatory Knowledge: Maintain up‑to‑date knowledge of global GVP regulations (Good Pharmacovigilance Practices) and industry trends, identifying new requirements to ensure a high level of quality is maintained internally.
Position Qualifications & Experience
- Academic Background: BS degree in a relevant biological science, pharmacy, or related science discipline.
- Professional Experience: Quality Assurance experience within a GVP‑regulated environment, demonstrating a strong understanding of drug safety operations and regulatory frameworks.
- Audit Expertise: Experience in audit and inspection management, with a clear understanding of the requirements for quality assurance in the pharmacovigilance discipline.
- Communication Skills: Excellent interpersonal and negotiation skills, with the ability to work effectively with multinational teams and external suppliers across different regions.
- Organizational Agility: Strong analytical and problem‑solving skills, with the ability to work with limited supervision and manage a schedule that includes up to 50% travel.
Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please let us know.
Auditor - PV in Maidenhead employer: CSL
Contact Detail:
CSL Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Auditor - PV in Maidenhead
✨Tip Number 1
Network like a pro! Reach out to professionals in the pharmacovigilance field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream auditor role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GVP regulations and recent trends in drug safety. We recommend creating a cheat sheet of key points to discuss, so you can impress your interviewers with your expertise!
✨Tip Number 3
Showcase your audit experience! During interviews, share specific examples of audits you've conducted and the impact they had. We want to see how you’ve navigated complex environments and contributed to compliance improvements.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search!
We think you need these skills to ace Auditor - PV in Maidenhead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that match the Auditor - PV role. Highlight your quality assurance experience and any relevant audit expertise to show us you’re the right fit!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about pharmacovigilance and how your background aligns with our mission at StudySmarter. Keep it engaging and personal!
Showcase Your Communication Skills: Since this role involves working with multinational teams, make sure to demonstrate your excellent interpersonal skills in your application. We want to see how you can effectively collaborate and negotiate with diverse stakeholders.
Apply Through Our Website: We encourage you to apply directly through our website for the best chance of success. It’s the easiest way for us to keep track of your application and ensure it gets the attention it deserves!
How to prepare for a job interview at CSL
✨Know Your Regulations
Make sure you brush up on global GVP regulations and any recent changes in the pharmacovigilance landscape. Being able to discuss these confidently will show that you're not just familiar with the basics, but that you’re proactive about staying informed.
✨Showcase Your Audit Experience
Prepare specific examples from your past audit experiences that highlight your ability to identify non-compliance trends and develop corrective actions. Use the STAR method (Situation, Task, Action, Result) to structure your responses clearly.
✨Demonstrate Communication Skills
Since this role involves working with multinational teams, practice articulating your thoughts clearly and concisely. Be ready to discuss how you've effectively communicated findings and recommendations to stakeholders in previous roles.
✨Emphasise Continuous Improvement
Think of ways you've contributed to improving standard operating procedures or audit processes in your past roles. Be prepared to share these examples, as they’ll demonstrate your commitment to quality and operational resilience.