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- Tasks: Conduct audits to ensure drug safety compliance and improve operational resilience.
- Company: Join CSL Seqirus, a leading global influenza vaccine provider.
- Benefits: Enjoy competitive benefits, including health support and a focus on well-being.
- Other info: Embrace a culture of inclusion and belonging at CSL.
- Why this job: Make a real impact in drug safety while working with diverse teams.
- Qualifications: BS degree in biological science and experience in quality assurance.
The predicted salary is between 45000 - 55000 £ 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.
Auditor - PV in Maidenhead employer: CSL Plasma
Contact Detail:
CSL Plasma 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. A friendly chat can lead to insider info about job openings that aren’t even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GVP regulations and recent trends in drug safety. We want you to show off your expertise and passion for the field when you get that chance to shine!
✨Tip Number 3
Practice your communication skills! Since this role involves working with multinational teams, being able to articulate your thoughts clearly and confidently is key. Try mock interviews with friends or mentors to get comfortable.
✨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 is tailored to the Auditor - PV role. Highlight your experience in quality assurance and pharmacovigilance, and don’t forget to mention any relevant audits you've conducted. We want to see how your skills match what we're looking for!
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 a perfect fit for our team. Keep it concise but impactful – we love a good story!
Showcase Your Regulatory Knowledge: Since this role involves navigating complex safety environments, make sure to highlight your understanding of global GVP regulations. We’re keen on candidates who stay updated with industry trends, so let us know how you keep your knowledge fresh!
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, it shows us you’re serious about joining our team at CSL Seqirus!
How to prepare for a job interview at CSL Plasma
✨Know Your Regulations
Make sure you brush up on global Good Pharmacovigilance Practices (GVP) regulations before your interview. Being able to discuss recent changes or trends in drug safety will show that you're not just knowledgeable but also genuinely interested in the field.
✨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 confidently. Think of scenarios where you've successfully negotiated or collaborated with stakeholders, and be ready to share those stories.
✨Emphasise Continuous Improvement
Be prepared to discuss how you've contributed to improving standard operating procedures in your previous roles. Highlight any initiatives you've led or been part of that enhanced quality assurance processes, as this aligns perfectly with the continuous improvement aspect of the job.