Brussels, Brussels Region, Belgium
Experienced Associate Director Research Development Quality and Compliance with a demonstrated history of working in the biotechnology industry. Skilled Safety Vigilance and auditing, Epidemiology, Oncology, CRO Management, Clinical Trials, and Regulatory Affairs. Strong business development professional graduated PharmD from University Paris XI. IRCA Certified Lead auditor ISO9001:2015
• Formulated and implemented the Global Quality Auditing strategy within GVP standards. • Led a dedicated team of auditors across multiple geographies, ensuring compliance with Worldwide Regulatory commitments. • Developed risk-based audit programs to enhance quality assurance and mitigate risks globally.
Ongoing development and operational success of the LOC functions responsible for GCP and GVP worldwide with alignment of affiliate initiatives, goals and activities with R&D QA goals. Ensure Audits conduct, local implementation of global standards and procedures. Supports regulatory inspections and partner audits of LOCs worldwide.
Manage and conduct audit activities associated with pharmacovigilance and clinical trial safety and ensure appropriate corrective and preventative actions are completed. Identify any potential systemic gaps, escalation to management and assist with the implementation of remediation plans. Give advisory/consultative capacity in compliance related safety matters. Support the activities for preparation, hosting and responses to regulatory agency inspections.
2011-2016 : Management and Conduct of pharmacovigilance audits worldwide for Pierre Fabre entities and License partners. Medical Devices Vigilance and Good Distribution Practice audits experiences. Establishing and maintaining processes and tools for the preparation, conduct, reporting and follow up of Pharmacovigilance audits and PSMF maintenance. Handling of CAPA and Supporting Regulatory pharmacovigilance and medical devices inspections 2005-2011 : PV Conpliance and SOP writing, training and support PV corporate teams and Department Heads. Hosting PV and Medical Device inspections. PV Regulatory Requirement Surveys worldwide. Preparation and Set up reporting rules in Argus worldwide safety database during production phase compatible ICH E2b transmission
Pan-European Registries and Epidemiological survey, Late Phase, Quintiles France: • Management of project activities and project team members. • Focal point for communication with Sponsor • Responsible for managing timelines, budget & costs and quality of projects deliverables • Support in clinical trial management (deliverables & finance) • Customer Managed missions (PV, retrospective study)