- Implementation and supervision of post-study, expanded access, and compassionate use programs- Submission to ANVISA of new participants for programs Preparation of annual reports for ANVISA and notification of program start and end - Communication with central and local teams - Supply control, forecasting preparation - Preparation of presentations with program evidence - Preparation of team meeting minutes- Request for medication release through Power Apps -… Show more - Implementation and supervision of post-study, expanded access, and compassionate use programs- Submission to ANVISA of new participants for programs Preparation of annual reports for ANVISA and notification of program start and end - Communication with central and local teams - Supply control, forecasting preparation - Preparation of presentations with program evidence - Preparation of team meeting minutes- Request for medication release through Power Apps - Interface with logistics team for medication release - Training of participating centers Show less

- Participation in protocol review - Centers feasibility assessment - Regulatory submission follow-up - Responsible for budget release for milestones - Quality and risk analysis Interface with vendors - Supply control Contract analysis, addenda and protocol amendments- Monitoring of studies and recruitment follow-up - Archiving of evidence gathered in MM check - Participation in follow-up meetings with the central team - Visions system update - Study… Show more - Participation in protocol review - Centers feasibility assessment - Regulatory submission follow-up - Responsible for budget release for milestones - Quality and risk analysis Interface with vendors - Supply control Contract analysis, addenda and protocol amendments- Monitoring of studies and recruitment follow-up - Archiving of evidence gathered in MM check - Participation in follow-up meetings with the central team - Visions system update - Study closure and monitoring of publication in journals/newspapers or congresses Show less

- Monitoring of medical activities - Organization of KPI-derived data - Preparation of presentations with monthly results

Iniciação científica na área de imunologia