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Experteer Overview In this role you ensure the Pharmacovigilance Quality Management System stays robust and compliant, guiding risk-based audit programs and inspection readiness. You lead QA activities for external partners and internal processes, driving continuous improvement across GVP. You collaborate with the Patient Safety function to align with global regulations and company policies, shaping a trustworthy pharmacovigilance footprint. Your work directly supports safer patient outcomes and regulatory excellence. Compensaciones / Beneficios • Maintain the pharmacovigilance quality system in line with policy, ICH, EU GVP and regulatory requirements. • Design and manage the GVP risk-based audit plan; perform or oversee audits of affiliates, partners, CROs/vendors, and internal processes. • Report audit observations to management and close gaps until resolution. • Lead preparation and management of inspections by authorities and third parties; develop an inspection readiness plan. • Review and approve procedures and key documents to ensure regulatory alignment for Drug Safety. • Select and oversee outsourced QA activities for pharmacovigilance (audits, mock inspections, training). • Participate in due diligence of development products as needed. • Promote continuous improvement of the GVP Quality System based on audit outcomes and regulatory changes. Responsabilidades • Knowledge of GVP, GMP, GCP; drug safety, clinical trials, data management, pharmacokinetics, statistics. • EU and non-EU pharmacovigilance regulations. • QA training, especially in Ru0026D areas. • Proficiency in English. Requisitos principales •