• Assist in the development, management, and implementation of activities to support the global PV QA audit program • Implement and assess PV quality assurance strategies, organizational and operational needs• Primary internal customer base includes Global Safety, LOCs, Risk Management, QPPVs, GRA • Assess adherence to quality standards and compliance with applicable regulations and guidelines, and GSK policies and procedures. Independently plan, lead, and conduct routine and complex audits of PV activities within Global Safety, LOCs, External Service Providers, Licensing Partners to assure compliance with regulations, GSK policies and procedure, and applicable local regulations• Collaborate with Global Safety staff and RMs to interpret international regulations and guidelines and establish and monitor compliance for acceptable standards for activities• Support regulatory inspections for related regulatory authority inspections of GSK• Assist and contribute to development of periodic reports and other information to identify trends and develop improvements across the business• Represent PVQA to central and local safety teams in relation to compliance, quality improvement, business redesign initiatives and risk assessment• Provide expert advice in relation to obtaining compliance, quality improvement, process and program initiatives and risk assessment,• Maintain an up-to-date and in-depth knowledge of appropriate national and international PV legislation and guidelines that affect the business• Maintain an in-depth knowledge of PV processes and procedures• Involvement in / presentation at external conferences• Educate, guide and influence GSK management and staff on best quality and compliance practices, especially as they relate to areas of identified responsibility• Build and maintain beneficial working relationships with all internal and external customers• Develop / deliver training on PV audit• Interact with regulatory agencies

Worldwide Audits (Pharmacovigilance and Vigilance of Medical Devices) including:– Vigilance system of Corporates, Affiliates, Distributors and Service Providers– Medical Information system• Training (Medical devices legislation)• Regulatory intelligence (participation in the French part of the monthly bulletin Safety Observer)• Regulatory assistance in pharmacovigilance• SOPs writing

•EU-QPPV•Act as a single pharmacovigilance contact point for the competent authorities andthe EMA•Provide input into the preparation of regulatory action in response to emergingsafety concerns (variations, urgent safety restrictions, and communicationto patients and healthcare professionals)•Ensure the conduct of pharmacovigilance activities and the submission of all pharmacovigilance-related documents (e.g. ICSRs, PSURs, RMPs) is in accordance with the legal requirements and GVP•Establishment and maintenance of PSMF / SOPs/ SDEA•Regulatory watch and impact assessment• Participation in Audit/ inspection•Management of non-conformities/ deviations/ CAPA plan•KPI monitoring

• EMA certified Eudravigilance user (EVWEB, EVDAS)• Management of vigilance cases (Spontaneous cases, clinical trial, literature): Quality control (case narrative, MedDRA coding…), medical evaluation (WHO assessment, French method, Expectedness…), Database: Argus, ARISg, Safety easy, • Writing of safety cosmetovigilance and nutrivigilance reports• Pharmacovigilance literature watch• Pharmacovigilance regulatory watch• Investigation of pharmacovigilance cases by telephone and letters• Developing training tools covering the new Eudravigilance regulations (E2BR3) and EV tools (EVDAS, EVWEB, adrreports,…• Establishing compliance measures with the quality department (writing and review of standard operating procedures, training tools,...

I worked as a research engineer in the French Alternative Energies and Atomic Energy Center (CEA), where I conducted several projects in an autonomous and productive way. My main project aimed to develop several tools for the detection of the prion protein expression in response to some genotoxic stress used in chemo/radiotherapy. During those three years, I provided my scientific skills in the domain of molecular and cellular biology as well as in biochemistry to further develop my project. In addition, I developed my organisational and management skills by conducting interesting scientific projects. Moreover, I supervised a lab technician who became acquainted with the different tools that I developed.

I contributed to an interesting project that was initiated in a biotechnology start up based in CEA Grenoble where I developed an in vitro test to detect repair of DNA double strand breaks on a biochip.

Expression and purification of murine Rif1 C-terminal domain