Linda Tafo

Mission: Managing data in the pharmacovigilance database Good understanding of the e-CRF and the clinical database. Coding of products and adverse events. Writing narratives and delivering CIOMS for medical review. Business Objects requests' validation for listings extraction. Data entry of new pharmacovigilance events. Support Tools: Clintrial, Argus, Inform, Business Object

Mission: Melting of separate pharmacovigilance databases Update of the internal list of products and the internal dictionary. Coding of internal products and post-migration corrections. Extraction of AE details and validation of periodic listings (PSS and ASR reports) Data retrieval upon user’s (Clinical Medical Evaluators) requests Support Tools: Business Object, Clintrace 2.6 & 2.8, Access, WHO-DD

Mission : Update of the international pharmacovigilance database Re-transcription of 110 French cases archives de 110 into a renewed Excel format. Translation of CIOMS’ narratives from French to medical English. Quality control of the periodic reports (PSUR) follow-up calendar.

Mission: On a Phase III study in Cardiology (10500 Patients) at the Data Management department Validation of e-CRF data, discrepancies addressed according to study specific procedures. Testing of the database Oracle Clinical 4RDC. Quality control of Serious Adverse Events (SAE), Coding. Support Tools and Certificates: Oracle Clinical 4.5 RDC, GCP, Discrepancy management

Molecular Biology, Informatics