Auditor - GVP (Pharmacovigilance)

Location: King of Prussia, Pennsylvania, United States; up to 50% travel required.

Company

hirify.global is a global biotherapeutics company developing and delivering therapies across immunology, hematology, cardiovascular and metabolic, respiratory, and transplant areas.

What you will do

• Conduct external audits of pharmacovigilance vendors and service providers.
• Perform internal self-inspections of safety processes, systems, affiliates, and Local or Regional Safety Officer activities.
• Prepare audit reports, categorize findings by risk level, and recommend corrective and preventive actions.
• Identify non-compliance trends and systemic risks affecting pharmacovigilance system health and PSMF integrity.
• Improve audit standard operating procedures and develop risk-based compliance solutions with stakeholders.
• Maintain current knowledge of global Good Pharmacovigilance Practices regulations and industry trends.

Requirements

• Bachelor of Science degree in biological science, pharmacy, or a related scientific discipline.
• Quality Assurance experience in a GVP-regulated environment, with a strong understanding of drug safety operations.
• Experience managing audits and inspections within the pharmacovigilance discipline.
• Knowledge of ICH E2D(R1), E2A, E2B(R3), E2C(R2), and E2F guidelines.
• Knowledge of applicable United States and European pharmacovigilance regulations, including 21 CFR requirements, Directive 2001/83/EC, Regulation (EC) No 726/2004, and EMA GVP Modules I–XVI.
• Strong analytical, problem-solving, interpersonal, and negotiation skills; ability to work with limited supervision and multinational stakeholders.

Culture & Benefits

• Work within a global biotherapeutics organization serving patients in more than 100 countries.
• Collaborate with multinational internal teams and external partners.
• Benefits are provided by CSL, with additional well-being information available through the company.
• Inclusive workplace focused on belonging, curiosity, empathy, and a diverse workforce.