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Auditor - GVP
Quality in a Globalised Drug Safety Network
Quality in a globalised drug safety network is a matter of operational resilience as much as regulatory mandate. This role serves as a GVP Auditor within our Research & Development Quality audit programme, 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
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Audit Execution:
- Conduct assigned external audits of pharmacovigilance vendors and service providers.
- Execute internal self-inspections of safety processes, systems, and affiliates (Local/Regional Safety Officers (LSO/RSOs) activities).
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Reporting & Risk Categorisation:
- Develop and issue comprehensive Audit Reports, categorising findings by risk level.
- Provide recommendations for corrective and preventive actions (CAPA) related to drug safety.
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Trend Analysis:
- Identify non-compliance trends and systematic risks within the PV discipline.
- Communicate findings to line management and functional leads to support PV system health and ensure integrity of the PSMF.
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Continuous Improvement:
- Support initiatives to improve SOP for audit conduct.
- Partner with stakeholders to develop risk-based, compliant solutions.
- Ensure adherence to EMA Guidelines on Good Pharmacovigilance Practices (GVP Modules) and applicable global/regional regulatory requirements.
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Regulatory Knowledge:
- Maintain up-to-date knowledge of global GVP regulations and industry trends.
- Support internal quality and compliance.
Position Qualifications & Experience
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Academic Background:
- BS degree in a relevant biological science, pharmacy, or related discipline.
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Professional Experience:
- Quality Assurance experience within a GVP-regulated environment.
- Strong understanding of drug safety operations and regulatory frameworks.
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Audit Expertise:
- Experience in audit and inspection management.
- Clear understanding of quality assurance in the pharmacovigilance discipline.
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Communication Skills:
- Excellent interpersonal and negotiation skills.
- Ability to work effectively with multinational teams and external stakeholders across different regions.
Working Knowledge Of:
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ICH Guidelines:
- ICH E2D(R1)
- ICH E2A
- ICH E2B(R3)
- ICH E2C(R2)
- ICH E2F
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US Regulations:
- 21 CFR Part 314.80 (for drugs)
- 21 CFR Part 600 Subpart D (for biologics)
- 21 CFR Part 4 (Combination product/duplicate reporting prevention)
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EU Directives/Regulations:
- 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)
Organisational Agility
- Strong analytical and problem-solving skills.
- Ability to work with limited supervision.
- Manage a schedule including up to 50% travel.
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