Fernando Barion Email & Phone Number

- Processing, monitoring and following up non-serious/serious adverse events reports from several spontaneous/solicited sources as marketing surveillance, marketing programs and clinical trials, following Pharmacovigilance procedures and guidelines;- Adverse events seriousness criteria classification according to guidelines and procedures established in international law;- Quality cases review in accordance with global requirements;- Responsible for external and internal training on Pharmacovigilance;- Strong participation in development of support training material, assisting the application of specific training for Patient Oriented Programs with regards to procedures to be followed for communication of adverse events reports; - Strong involvement with the Novartis on-line Adverse Events notification tool for local Patient Oriented Programs; - Support local standard procedures on developing, updating and reviewing activities; - Support key performance indicators control; - Participation in internal and external audits and inspections from regulatory authorities.

- Collecting, monitoring and following-up adverse event reports experienced in Brazil with BMS marketed products;- Forwarding Health Care Professionals' adverse event reports to Health Authority as per local legislations;- Forwarding clinical trials’ serious adverse event reports to Health Authority as per local legislations;- Training of critical non-Pharmacovigilance staff;- Development of Pharmacovigilance training materials, as appropriate.- Supporting the implementation and supervision of the current Call Center Service focused on Pharmacovigilance and Medical Information;- Performing reconciliation among Corporate Safety Database and Call Center and Medical Information systems.- Participation in internal audits and inspections of regulatory authorities;

- Prepare required documentation for CONEP-CEP-ANVISA submission and approval. - Provide support for Site Monitors in Research Centers. - Provide support for Start-up in the follow-up documents submitted to ANVISA. - Support for Site Managers in daily activities and management of Clinical Studies. - Direct contact with research centers, supporting the Site Management team. - Active participation in the process for importing study drug. - Attendance at conferences.

- Knowledge of national and international norms for clinical research. - Coordination of Phase II to IV Clinical Studies. - Preparation of regulatory packages, sending semi-annual reports and other documents for review and approval by the IRB and CONEP. - Inclusion (under supervision of a physician) of patients in clinical studies. - Dispensing immunosuppressive drugs for Clinical Trials that are not distributed by the Health Department.- Preparation of study medication infusion, following strict protocol of preparation. - Follow-up of patients included in clinical studies hospitalized and at outpatient clinic. - Fulfill Case Report Forms for Clinical Studies.- Participation in internal audits and inspections of regulatory authorities;