United Kingdom
Senior Pharmacovigilance Specialist with 13+ years of experience across Big Pharma and global CRO environments, delivering compliant drug safety operations within MHRA, EMA, FDA, and PMDA-regulated frameworks.Specialist in PSUR reporting, PBRER scheduling and maintenance, ICSR lifecycle governance, literature surveillance, and regulatory inspection support. Maintained 99.5% quality compliance across high-volume safety operations and contributed to a successful FDA inspection outcome with zero critical findings.At GlaxoSmithKline, supported aggregate reporting activities and quality oversight of approximately 300 ICSRs per month across vaccines, HIV, medical devices, and pharmaceutical portfolios. Conducted structured daily literature surveillance (150+ articles per day) and implemented full-text selection criteria that reduced procurement costs by 30–40% while maintaining surveillance integrity.Experienced in Argus Safety, MedDRA coding, EU/UK GVP requirements, vendor audits, SOP governance, and safety data exchange activities. Known for maintaining inspection-ready documentation standards and delivering consistent regulatory reliability in high-volume environments.Open to UK-based contract and permanent Pharmacovigilance opportunities.
Lead validation of pharmacovigilance systems supporting case processing and signal detection functions within regulated environments. Independently verify case counts, compliance metrics, and reporting calculations to ensure regulatory accuracy and audit defensibility. Conduct structured root cause analysis to resolve data discrepancies, strengthening system reliability and inspection readiness. Support documentation control and validation standards in alignment with EU/UK GVP and regulatory expectations.
Led PSUR preparation and quality control activities and managed PBRER scheduling and maintenance across global markets in alignment with MHRA, EMA, FDA, and PMDA regulatory frameworks. Oversaw quality review of approximately 300 ICSRs per month across vaccines, HIV, medical devices, and pharmaceutical portfolios, maintaining regulatory compliance standards. Achieved sustained 99.5% quality compliance across safety case operations and aggregate reporting activities. Supported FDA inspection readiness activities, contributing to successful inspection outcome with zero critical findings. Conducted structured daily literature surveillance (150+ articles per day) to identify emerging safety signals and potential risks. Implemented evidence-based full-text selection criteria, reducing literature procurement costs by 30–40% while maintaining surveillance integrity. Conducted vendor audits and reinforced adherence to EU and UK GVP requirements. Mentored and trained 20+ team members, strengthening process consistency and compliance awareness.
Managed end-to-end ICSR lifecycle including case evaluation, MedDRA coding, narrative development, and submission within MHRA, EMA, and FDA regulatory timelines. Conducted high-volume literature surveillance (1,500+ articles daily) in alignment with ICH-GCP and EMA guidance to identify safety signals across sponsor portfolios. Ensured timely and compliant case submissions while maintaining inspection-ready documentation standards. Supported sponsor audits and maintained adherence to EU GVP requirements within a CRO delivery model.
Processed high-volume Individual Case Safety Reports (ICSRs) in compliance with ICH-GCP, EMA, and MHRA regulatory standards. Conducted quality control reviews to ensure case accuracy, regulatory completeness, and submission timeline adherence. Achieved 100% quality score recognition and received multiple performance awards for sustained case processing excellence. Supported User Acceptance Testing (UAT) activities for safety systems, contributing to process optimisation initiatives. Trained and supported new team members, strengthening workflow consistency within a global CRO environment.