Compliance Manager within the PV Department of a large Global Pharma Company, supporting compliance monitoring, audit and inspection activities and maintaining the Pharmacovigilance System Master File (PSMF)• Provided key support during PV inspections and audits conducted at the global and local affiliate offices • Reviewed inspection and audit observations; performed root cause analysis, challenged observations where appropriate and developed corrective and preventative action plans and effectiveness checks• Collated and reviewed aggregate submission data to monitor compliance against applicable regulations and company agreements, and prepared metrics and trend analyses for senior management • Investigated non-compliance in regulatory submissions and safety data exchange with partners, initiated Quality Events and ensured the implementation of corrective measures by appropriate parties • Authored Quality Management System documents; SOPs, work instructions and training materials• Acted as the Company expert on the PSMF; performed project management in relation to maintenance and continuous improvement; managed stakeholder engagement and content delivery across the organisation (Quality Assurance, Clinical, Regulatory and Medical Affairs) to ensure the PSMF continued to meet and exceed GVP II requirements; interviewed in multiple GVP Inspections as the PSMF subject matter expert; integrated the PSMFs from numerous company acquisitions; developed regional PSMFs to support local affiliate offices in Eurasia and the Middle East; supported marketing applications and licence maintenance activities

Provided lead lifecycle Pharmacovigilance support on marketed and in-development products, working closely with the QPPV, physicians and Clinical, Regulatory and Medical Affairs teams• Supported the ongoing benefit-risk assessment of products, performed regular signal detection and analysis• Collaborated on CCSI updates and supported their implementation into SmPCs and PiLs • Provided lead PV representation on studies and programmes at Global and Local levels• Delivered significant contributions to protocols, DSURs, IBs, PSURs/PBRERs and RMPs• Performed case processing on solicited, spontaneous and literature cases; data entry, causality and expectedness assessments, narrative writing, Peer QC, unblinding and CIOMS generation• Performed global expedited and periodic report submissions• Responded to Competent Authority and Medical Information requests• Managed partner company commitments including instances of non-compliance, generated pharmacovigilance agreements, established and maintained excellent partner relations• Oversaw vendor activities in relation to safety report production, case processing and submissions• Performed user testing on new safety systems• Performed ongoing regulatory intelligence activities to ensure correct safety reporting • Wrote and reviewed departmental SOPs, Work Instructions and training materials• Delivered training on products, systems and processes, mentored staff and interviewed new hires