Adrián Lopez Casanello Email and Phone Number

Implement proprietary technology for clinical & PV data management in phase I-IV studies and PV organizations.- JAZZ CLINICAL:EDC application and infrastructure, SUSAR distribution to investigators & IRB/ECRandomization and drug supply management(S)AE reporting- JAZZ SAFETY:PV database management system, ICH E2B(R3) compliant

Product risk management and safety monitoring (e.g., signal management, PSUR) for the oncology products developed at the local manufacturing site. Qualified Person in PV to ANMAT ("Responsable de Farmacovigilancia"). Regulatory intelligence (networking with external interfaces). Strategic involvement in processes and decisions with other company areas (e.g. regulatory affairs). Screening of the local scientific literature. Quality and training management. PV Agreements negotiation with third parties.

Product risk management and safety monitoring (e.g., signal management, PSUR) for local and regional products. Qualified Person in PV to ANVISA. Regulatory intelligence (networking with external interfaces). Lead the local Case Processing Unit. Strategic involvement in processes and decisions with other company areas (e.g. marketing). PV processes in clinical trials, post marketing activities with contact to health-professionals/patients and new business opportunities. Quality and Training management. Talent management and team leadership. PV Agreements negotiation with third parties.

Deputy of the Head of Regional PV Latin America. Compliance with local PV legislations in South America countries (except Brazil). Qualified Person in PV to ANMAT ("Responsable de Farmacovigilancia"). Regulatory Intelligence in South America countries. Risk management. Safety monitoring for local and regional products (e.g. signal management, PSUR). Strategic involvement in processes & decisions with other areas (e.g. quality assurance). PV processes in clinical research, post marketing activities and new business opportunities. Quality and Training management in South America countries. Talent management. PV Agreements negotiation with third parties.

Compliance with local PV legislations. Product surveillance for local and regional drugs. Review post-marketing programs with patient/health professional contact. Case processing and reporting, including clinical trial and post-marketing case reports. Qualified Person to ANMAT ("Responsable de Farmacovigilancia"). Regulatory intelligence. Coordination of local PV Agreements. PV training to company employees.

Ensure compliance with ICH-GCP guidelines, FDA CFR and local regulations in clinical research. Clinical site monitoring. Data management. Close support to the clinical team, maintains central study files (including regulatory documents) for assigned projects. Track study data in the clinical database and offer organizational expertise.