Rio de Janeiro, Brazil
Pharmacist graduated from the Federal University of Rio de Janeiro (UFRJ), with experience in Pharmacovigilance, Cosmetovigilange and Clinical Trials. Currently working as a Clinical Trial Assistant at Servier, contributing to the submission and conduction of clinical studies. I have two years of experience in pharmacovigilance and cosmetovigilance, focusing on drug safety monitoring, case analysis, translation and compliance with regulatory authorities. Additionally, I have experience in pharmaceutical assistance and scientific research, complemented by leadership and marketing experience in university projects, where I coordinated teams and promoted community engagement initiatives.
• Sponsor study file maintenance (TMF and eTMF); • Conducting Feasibility and qualification of centers; • Management of technical documents related to the study; • Preparation of the Informed Consent Form in accordance with local legislation; • Activities related to study Set Up and site start up; • Preparation of the regulatory package for the CEP/CONEP System, as well as follwing up the submissions and answering queries; • Archiving and quality control of documents related to clinical studies; • Monitoring support through review of the investigator's study file.
Pharmacovigilance, Cosmetovigilance and Medical Information: • Receipt and processing of Pharmacovigilance, Cosmetovigilance and Medical Information cases, including contact with patient and HCPs. • Follow-up of Pharmacovigilance and Cosmetovigilance cases. • Report of SAEs (marketed drugs) and SUSARs (clinical studies) to Local Competent Authority- ANVISA. • Translation of the cases and submission to Global Safety. • Tracking of CIOMS received from Global Safety. • Understanding of legislations and internal procedures for carrying out Pharmacovigilance/Cosmetovigilance/Medical Information tasks. • Clarification of Medical Information doubts request by HCP or patients. •Participation in reconciliation processes. • Tools and systems: Argus Safety (LAM), INTER-e-ST, Veeva, Veeva Vault, Music, Websop, MIC, MedDRA and VigiMed. Quality in Clinical Trials: •Analysis of clinical trials deviations and CAPA follow-up; •Monitoring the distribution of internal procedures and Quality assurance working groups; •Training organization: Assignments of initial and continuous trainings throught an eletronic platform, preparation and archiving of attendance sheets and certificates; •International contact with Clinical Study Support Manager (CSSM) to help in specific QA demands. •Verification, preparation and archiving of quality metrics and KPIs.
•Assisted in hospital pharmacy operations, including medication preparation and inventory management.
•Supported pharmaceutical assistance activities, focusing on patient care and medication management.
Scientific Initiation Student at the Laboratory of Microbial Biotechnology of Drugs (LaBiMFar) •Conducted research on enzymatic catalysis for pharmacological derivatives. •Studied free and immobilized lipases. •Analyzed stability and biochemical properties of enzymes. Project: Enzymatic catalysis in the production of pharmacological derivatives, focusing on the study of free and immobilized lipases, with the goal of identifying an efficient biocatalyst for the production of pharmacological derivatives, comparing stability and biochemical characterization.
•Responsible for organizing the commercial team •Development of performance indicators for monitoring results •Leadership and public speaking
•Prospecting new leads through commercial intelligence •Engaging with leads through active and passive prospecting •Conducting diagnostic meetings and proposals with potential clients