Gala Szapiro Email & Phone Number

Madrid, Comunidad De Madrid, España

Supervision of Pharmacovigilance (PV) Department staff within a specific region and project.Management of pharmacovigilance stand-alone studies.Lead/supervise PV set-up activities within a project.Safety Management Plan development.Training, mentoring and coaching.Coordination of periodic and aggregated safety reports in compliance with safety reporting regulatory requirements.Participation in PV-related inspections and audits.Development of Quality Standard Documents, work instructions, and other PV tools.

Madrid, Comunidad De Madrid, España

Safety Management Plan development.Deployment of project or product-specific safety databases.Coordination and preparation of periodic and aggregated safety reports in compliance with internal procedures, safety reporting regulatory requirements.Supervision of SAE reporting to client and other parties.Assistance in signal detection and analysis of similar events.Primary contact to clients, vendors, project teams and site teams on all project-specific safety issues.

Buenos Aires, Argentina

Safety reports processing.Participates in reconciliation of safety versus clinical database for SAEs.Prepares data outputs for Analysis of Similar Events for SUSAR cases.PV documentation filing.SAE tracker maintenance.SAE query management.

Buenos Aires, Argentina

Analysis of gene expression regulation in mammals. Management of molecular biology techniques: PCR, real time PCR, Western Blot, immunocytochemistry and immunohistochemistry.Supervised by Dr. Monica Vazquez-Levin.

Buenos Aires, Argentina

Quantification of the production of cell wall degrading enzymes, by Macrophomina phaseolina. Supervised by Dr. Laura Levin and Dr. Marcela Ramos.