Auditor - GVP

Main Responsibilities

• Coverage of 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).
• Development and issuance of comprehensive Audit Reports, categorizing findings by risk level and providing recommendations for corrective and preventive actions (CAPA) related to drug safety.
• Identification and communication of non-compliance trends and systematic risks within the PV discipline to line management and functional leads.
• Support of initiatives to improve standard operating procedures (SOPs) for audit conduct and collaboration 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.
• Maintenance of up-to-date knowledge of global GVP regulations (Good Pharmacovigivalence 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.
• Knowledge: 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.