Auditor - GVP

About the Role

This role serves as a GVP 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 findings and non-compliance trends that could impact the reliability of our pharmacovigilance system. We seek an experienced auditor who can navigate complex safety environments and collaborate with stakeholders to develop corrective actions ensuring long-term systemic stability.

Responsibilities

• 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).
• Develop and issue comprehensive Audit Reports, categorizing findings by risk level and providing recommendations for corrective and preventive actions (CAPA) related to drug safety.
• 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.
• Support initiatives to improve standard operating procedures (SOPs) for audit conduct and partner with stakeholders to develop risk-based, compliant solutions ensuring compliance with EMA Guidelines on Good Pharmacovigilance Practices (GVP Modules) and applicable global and local regulatory requirements.
• Maintain up-to-date knowledge of global GVP regulations (Good Pharmacovigilance Practices) and industry trends to support internal quality and compliance.

Requirements

• BS degree in a relevant biological science, pharmacy, or related science discipline.
• Quality Assurance experience within a GVP-regulated environment, demonstrating a strong understanding of drug safety operations and regulatory frameworks.
• Experience in audit and inspection management, with a clear understanding of quality assurance requirements in the pharmacovigilance discipline.
• Excellent interpersonal and negotiation skills, with the ability to work effectively with multinational teams and external stakeholders across different regions.
• Strong analytical and problem-solving skills, with the ability to work with limited supervision and manage a schedule that includes up to 50% travel.

Skills

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)