Baya KDROUCI BENGUERFI

Supporting multinational clinical trials across North Europe, UK and DACH regions.

Clinical Safety Operations

• Manage and oversee solicited safety reportable events (SAEs, AESIs and protocol-defined safety events) throughout the clinical trial lifecycle, ensuring compliance with study protocols, GCP, EU CTR and global pharmacovigilance requirements.
• Perform quality review of safety documentation and ensure timely transmission of safety information and follow-up reports to Patient Safety and Pharmacovigilance (PSPV).
• Coordinate resolution of pharmacovigilance queries with Clinical Study Managers, Site Monitors, investigators and PSPV to ensure complete and compliant safety case processing.
• Contribute to safety reconciliation activities between clinical and pharmacovigilance systems, ensuring consistency, traceability and data quality.
• Ensure accurate filing and maintenance of Clinical Safety documentation within eTMF and applicable clinical systems.

Clinical Safety Oversight

• Oversee end-to-end safety reporting activities including SUSARs, SASRs, DSURs and regulatory submissions to Health Authorities, Ethics Committees and investigators across multiple European countries.
• Monitor compliance with local and global regulatory reporting requirements and proactively identify and escalate risks affecting safety deliverables.
• Review Clinical Safety deviations, contribute to trend analysis and support implementation of corrective and preventive actions (CAPAs).
• Support inspection readiness by ensuring completeness, traceability and quality of Clinical Safety documentation and TMF content.

Regional Leadership

• Act as Regional Point of Contact (POC) for Clinical Safety activities across Germany, Switzerland and Austria, providing operational guidance on regulatory requirements, reporting timelines and escalation pathways.
• Coordinate Clinical Safety activities across North Europe, UK and DACH clusters while ensuring harmonized implementation of global processes.
• Lead European working groups focused on Inspection Readiness and harmonization of Clinical Safety processes across regional teams.
• Mentor new Clinical Safety team members and act as Subject Matter Expert (SME) for regional Clinical Safety processes.

Audits and Inspection Readiness

• Act as Front Room Clinical Safety representative during sponsor and regulatory audits, responding directly to auditor questions regarding Clinical Safety processes, safety reporting and regulatory compliance.
• Present Clinical Safety documentation including TMF content, safety reports and tracking tools, ensuring accuracy, traceability and inspection readiness.
• Support audit preparation and contribute to CAPA implementation and follow-up activities.

Key Achievements

• Appointed Regional Clinical Safety Point of Contact for Germany, Switzerland and Austria.
• Successfully supported the transition from Clinical Trials Directive (CTD) to Clinical Trials Regulation (CTR) across multiple European countries.
• Lead cross-functional initiatives to strengthen inspection readiness and harmonize Clinical Safety processes across Europe.

• Managed the end-to-end lifecycle of Individual Case Safety Reports (ICSRs) for both clinical trial and post-marketing cases, ensuring compliance with global pharmacovigilance procedures and regulatory timelines.
• Performed case intake, triage, prioritization, data entry, MedDRA and WHO dru coding, narrative writing and quality review using ARGUS Safety and ARISg.
• Reviewed case documentation for completeness, identified missing information and coordinated follow-up activities with affiliates, investigators and Drug Safety Physicians.
• Collaborated with cross-functional stakeholders to ensure accurate safety data collection, case processing and application of product-specific safety conventions.
• Supported reconciliation activities and maintained data consistency across safety systems.
• Contributed to timely expedited reporting through accurate and compliant case processing.
• Participated in continuous process improvement initiatives and supported implementation of updated pharmacovigilance procedures.

Key Achievement

Successfully contributed to the migration from ARGUS Safety to ARISg, supporting data quality and business continuity.

• Managed the safety activities for a 500-patient non-interventional HIV clinical study.
• Performed the complete ICSR lifecycle including case intake, duplicate search, triage, data entry, quality review and follow-up.
• Coordinated SAE reconciliation between clinical and safety databases.
• Collaborated with CROs to resolve discrepancies and ensure complete safety documentation.
• Conducted retrospective quality review of study ICSRs and supported CAPA implementation.

Achievement

Received an internal award for contribution to the successful management of the HIV clinical study.

Key Achievement

• Managed end-to-end processing of ICSRs for marketed products, ensuring compliance with global pharmacovigilance procedures and regulatory timelines.
• Performed case prioritization, data entry, MedDRA coding, quality review and expedited reporting to Health Authorities.
• Monitored daily case workflows and ensured timely processing of safety cases in accordance with internal procedures and global reporting requirements.
• Managed the Drug Safety shared mailbox and coordinated case assignment and follow-up activities.
• Supported safety data reconciliation and maintained consistency between safety databases and source documentation.
• Prepared line listings and pharmacovigilance reports for Health Authorities and Regional Pharmacovigilance Centers.
• Contributed to Health Authority inspection readiness through preparation of safety documentation, quality review activities and participation in regulatory inspections.
• Updated quality system documents and supported continuous improvement initiatives.
• Served as SME and trainer, providing guidance to new team members on pharmacovigilance processes and regulatory requirements.

Successfully coordinated the processing of more than 400 priority safety cases received under a Temporary Authorization for Use within critical regulatory timelines.