Auditor - GVP

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 documenting it. 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. Maintain up‑to‑date knowledge of global GVP regulations (Good Pharmacovigilance Practices) and industry trends, to support internal quality and compliance. Qualifications 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 the requirements for quality assurance in the pharmacovigilance discipline. 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); 21 CFR Part 4 (Combination product/duplicate reporting prevention); Directive 2001/83/EC (as amended); Regulation (EC) No 726/2004; Commission Implementing Regulation (EU) No520/2012; EMA GVP Modules (I–XVI + product/population‑specific modules). Strong analytical and problem solving skills, with the ability to work with limited supervision and manage a schedule that includes up to 50% travel. Equal Opportunity Employer. CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please contact us. #J-18808-Ljbffr CSL Plasma Inc.