Zoe Simmonds Email & Phone Number

An Associate Director within Pharmacovigilance & Patient Safety with well over a decade of working within a clinical research organisation; extensive pharmacovigilance expertise and a thorough understanding of pharmacovigilance processes, regulations and systems. Management and oversight of a global (Europe and Asia Pacific) Pharmacovigilance Management team with over 75 Pharmacovigilance professionals responsible for ADR Management through safety regulatory reporting for Phase I-IV clinical trials, post marketing and devices. Responsible for maintenance of KPI standards, quality compliance in alignment with contractual obligations, regulatory requirements and SOP’s. CAPA Management and route cause analysis leading to process improvement and governance and SOP updates as necessary. Serves as primary business unit pharmacovigilance contact for internal and external stakeholders, vendors, sponsors and auditors and inspectors to ensure regulatory requirements and compliance deliverables are adhered to.

Listed skills include Pharmacovigilance, Regulatory Reporting, Safety Case Management, Line Management, and 32 others.

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  Swansea University

  Direct Entry Midwifery