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- Tasks: Conduct audits to ensure drug safety compliance and develop corrective actions.
- Company: Join a leading global pharmaceutical company committed to innovation and inclusion.
- Benefits: Competitive salary, travel opportunities, and a focus on professional growth.
- Other info: Dynamic role with up to 50% travel and a commitment to diversity.
- Why this job: Make a real impact on drug safety and contribute to global health.
- 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.
- 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).
- Support initiatives: 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.
- 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.
- Skills: Strong analytical and problem-solving skills, with the ability to work with limited supervision and manage a schedule that includes up to 50% travel.
Pharmacovigilance auditor in Reading employer: CSL Behring
Contact Detail:
CSL Behring Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Pharmacovigilance auditor in Reading
✨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 job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GVP regulations and recent trends in drug safety. We recommend practising common interview questions with a friend to boost your confidence and ensure you shine during the real deal.
✨Tip Number 3
Showcase your audit expertise! Bring examples of past audits you've conducted and the impact they had on compliance and safety. We love seeing candidates who can demonstrate their analytical skills and problem-solving abilities.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always on the lookout for passionate individuals who align with our mission of inclusion and belonging.
We think you need these skills to ace Pharmacovigilance auditor in Reading
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in pharmacovigilance and quality assurance. We want to see how your skills align with the role, so don’t be shy about showcasing relevant projects or audits you've conducted.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about drug safety and how your background makes you the perfect fit for our team. Keep it engaging and personal – we love to see your personality!
Showcase Your Regulatory Knowledge: Since this role involves navigating complex regulations, make sure to mention your familiarity with global GVP regulations. We’re looking for someone who stays updated on industry trends, so any recent training or certifications can really boost your application.
Apply Through Our Website: We encourage you to apply directly 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 culture there!
How to prepare for a job interview at CSL Behring
✨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 Analytical Skills
Be ready to discuss how you've used your analytical skills to solve problems in previous roles. Think of instances where you had to analyse data or trends and how that led to improvements in safety processes or compliance.
✨Engage with Stakeholders
Since collaboration is key in this role, prepare to talk about how you've worked with various stakeholders in the past. Highlight your communication skills and how you’ve successfully partnered with others to implement risk-based solutions.