Auditor - GVP
Not disclosed
Salary
Not disclosed by employer
£48,200
Going rate
Skilled Worker going rate
This role likely qualifies for a Skilled Worker visa
SOC 2482 (85% match) is an eligible occupation, with a going rate of £48,200, and CSL is a licensed sponsor. That is our reading of the rules. Whether they issue a Certificate of Sponsorship is still their call.
This could also be SOC 2421 (Chartered and certified accountants, Qualified auditor role, but focus is GVP compliance not finance). We read the code off the advert, so it is our best guess, not the employer's.
About the role
Main Responsibilities
- Audit Execution: Conduct assigned external audits of pharmacovigilance vendors and service providers, as well as internal self-inspections of safety processes, systems, and affiliates (including Local/Regional Safety Officers (LSO/RSOs) activities).
- 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.
- Trend Analysis: Identify non-compliance trends and systematic risks within the PV discipline, communicating these findings to line management and functional leads to support PV system health and protect the integrity of the PSMF documenting it.
- Continuous Improvement: Support initiatives to improve standard operating procedures (SOPs) for audit conduct and partner with stakeholders to develop risk-based, compliant solutions that ensure compliance with EMA Guidelines on Good Pharmacovigilance Practices (GVP Modules), and applicable global and local regulatory requirements..
- Regulatory Knowledge: Maintain up-to-date knowledge of global GVP regulations (Good Pharmacovigilance Practices) and industry trends, to support internal quality and compliance.
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 stakeholders across different regions.
- Working Knowledge of:
- ICH E2D(R1), E2A, E2B(R3), E2C(R2), and E2F Guidelines
- 21 CFR Part 314.80 (for drugs), 21 CFR Part 600 Subpart D (for biologics) and 21 CFR Part 4 (Combination product/duplicate reporting prevention)
- Directive 2001/83/EC (as amended)
- Regulation (EC) No 726/2004
- Commission Implementing Regulation (EU) No 520/2012
- EMA GVP Modules (I–XVI + product/population-specific modules)
- 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.
This description is the source posting as it read when we added it. We are not affiliated with CSL, so check their own site for the current details.
Where this offer sits in the market
SOC 2482 · UK · ONS ASHE 2025 · ~137k in sampleSimilar sponsored roles
See all UK visa jobsNo close matches live right now.
Browse more sponsored jobs at CSLAbout sponsorship for this role
Does this job guarantee visa sponsorship?
Not necessarily. CSL holds a sponsor licence, but sponsorship for a specific hire is always the employer's decision. Be upfront in your application that you'll require it.
What salary is needed for this role to be eligible?
The offer must clear both the general threshold and the SOC 2482 going rate of £48,200. New-entrant and shortage discounts can lower it.