Karima Ghioua

Background

About Karima Ghioua

Drug & Medical Device Safety Physician – 12 years experience in pharmacovigilance Subcontractor for: Global Sanofi/Genzyme, Global GlaxoSmithKline Biologicals, Global Besins Healthcare, WITTYCELL, InnaVirVax and UCB affiliate. Responsabilities: Review, analysis and evaluation of ICSRs when requested. Literature screening. Assisting or performing medical analysis and assessment of specific safety questions and providing advice on safety related medical questions to central and local Safety departments or any other relevant staff (QA, Regulatory affairs, labelling, Medical affairs, affiliates, Health Authorities, healthcare professionals…) Providing medical input to the evaluation and validation of safety signals and presentation to responsible committee. Review of clinical safety data, protocols and study reports. Review and approval of company publications. Contribution to the marketing authorization renewals, Health Authorities inspections and audits. Response to ad hoc Health Authorities questions and requests. Responsible on the safety reports writing (PSUR, PBRER, CO, SER, HHE, Survey) and response to related HA questions (PRAC, FDA…) Contribution to product alerts management and response to any related safety question. Contribution to and coordination of Benefit/Risk evaluation report for assigned products. Contribution to RMP writing and follow up. Contribution to divestment projects, review and approval of SDEA. Contribution to labelling working group for global and local labelling updates and presentation to responsible committee. Safety database testing and set up Contribution to SOP writing and approval Therapeutic areas: 1- Sanofi/Genzyme- Cardiology - Infectious diseases (mainly malaria) and Rheumatology - Biosurgery medical devices (of Genzyme)- Psychiatric and Neurological diseases (CNS° 2- GSK Bio- Vaccines 3- Besins healthcare- Endocrinology 4- UCB Pharma- Rheumatology - Immunology and allergic condition - Medical devices 5- WITTYCELL- Orthopedics Biosurgery 6- InnaVirVax- Vaccines