Responsible for leading and entire workflow for 3 expanded access clinical trial projects. I was the point of contact with the study sponsor for submitting drug safety information and adverse events and communicating with research centers to capture more detailed information on adverse events or situations of relevant medical interest. This involved an average of 10 contacts per month for adverse event reporting.I conducted regulatory affairs submissions for an average of 4 pharmacovigilance cases per week to the local regulatory authority.As part of safety profile monitoring, I was also responsible for sending safety alert notifications to clinical trials study center.Additionally, I provided support in other pharmacovigilance projects, including data entry into the database, quality control activities, preparation of lifecycle safety data reports, preparation of lifecycle safety submission dossiers, and assistance in quality timeline management.

I worked on pharmacovigilance projects for various clients in the following therapeutic areas: Oncology, Hematology, Immunotherapy, Neuroscience, Rheumatoid Arthritis, and Cystic Fibrosis.In the Roche Brazil project, I worked as a pharmacovigilance analyst, performing routine reception and processing of drug safety information and adverse events in the client's database, quality review, and regulatory package assembly. We underwent both internal and external audits by regulatory bodies, achieving good performance in the quality of processes and information processed at the Brazil level. Due to this result, the client expanded the scope of activities for us to process safety information for Roche Latin America.I performed trilingual translation of technical documents in the following languages: Spanish - English, Spanish - Portuguese, and English - Portuguese.I was also involved in the following activities:- Support in regulatory submission projects for the local authority, including the translation of the local dossier submitted to the local health authority.

Responsible for activities related to technical/medical information and patient safety, as well as support in regulatory affairs activities.Conducted scientific review and analysis of safety profile information and clinical trial data from Phase II and III for Pegfilgrastim. Developed the PV management plan and risk minimization strategy in response to the GFRAM/ANVISA drug registration requirement.Provides support for regulatory affairs with the following responsibilities:- Submission of bioequivalence study protocols to GESEF, commercialization reports, and pricing requests to CMED.- Compilation of registration dossiers for clone product, post-registration changes, and responses to requirements focusing on bioequivalence and bioavailability studies.

Responsible for all consumer service activities, technical/ medical information, and pharmacovigilance.During my activities in medical information and pharmacovigilance,I act as a co-host auditor for an internal pharmacovigilance inspection between affiliates (Brazil and India). I conducted the inspection remotely, based on a questionnaire, documentation review, and procedures. The format followed the EU GVP guidelines; however, the references for the audit were the applicable local regulations (RDC nº 4/2009).I created a repository, an index by subject, to standardize and maintain a history of inquiries from healthcare professionals. This standardization made the research and review of literature more efficient, facilitating the delivery of technical and/or medical information about medications to healthcare professionals and patients, reducing the average response time from 5 days to an average of 3-2 business days.Preventive technical guidance regarding the 3 cases of lack of efficacy with cisatracurium besylate and 10 cases of severe pain during paclitaxel administration at ICESP. Through the evaluation of medical reports on the seriousness and severity of the cases and the review of medical literature, we created a technical document that was made available along with the respective medications.I created an automated presentation to be used during the onboarding of all new employees and during the annual pharmacovigilance training refreshers.At the end of each month, I performed reconciliation of received reports to ensure the integrity of the monthly monitoring of the safety profile of a 30-medication portfolio.I also performed the following activities:- Compilation and review of medication safety information for submission of the Periodic Safety Report to ANVISA.- Submission of bioequivalence study protocols to GESEF, commercialization reports, and price requests to CMED.- Technical support and pharmacovigilance training for the sales force.

Validation and transfer of pharmaceutical data in the system transition from Zoetis to Inovat (outsourced by AG3 Solutions) in a 3-month project.Organization in Excel to list, track, and validate data between SAP systems, operational procedures, forms, and pharmaceutical product documentation. This ensured the organization and reconciliation of all the company's standard operating procedures for the system migration (SAP, Veeva Vault, and Trackwise).

Within a 3-month period, we cleared a backlog caused by a technical failure in the NOTIVISA notification system, ensuring that technical complaint notifications from this system were registered in the company's internal database. Subsequently, a periodic verification procedure was created to ensure no notifications were missed in the future.I supported the adjustment of quality and techno-surveillance operational procedures and workflows, focusing on the following points:- Process mapping and identification of improvement points;- Training on the reporting system for techno-surveillance cases;- Providing guidance and support to the sales force and other employees to improve the capture of information in the technical complaint reporting process.I also monitored the progress of technical complaint investigations by contacting clients to obtain information on technical complaint cases and collecting additional information. Additionally, I finalized investigations by sending the final analysis report of the technical complaint to the client and, if applicable, submitting the report to health authorities in Brazil and abroad.

As a pharmacovigilance analyst for the Sanofi Group:- I performed pre-processing and appropriate classification (severity and seriousness) of adverse event cases and special situations in pharmacovigilance.- I organized the receipt and dispatch of processed cases, as well as, the management of the internal email inbox of the area.- I was responsible for maintaining the pharmacovigilance tracking and control spreadsheet (cases received, translated, and sent to the client).- Translate information into English on the specific form.- Submition of cases to the Sanofi Group for quality evaluation and internal processing.- Reconciliation of pharmacovigilance reports received and sent to the Sanofi Group.- I provided support for the quality control of translated information.

I provided support by conducting scientific reviews of treatment cost data in relation to treatment outcomes, focusing on pharmacoeconomics. I was responsible for organizing and controlling all study documentation to ensure compliance for audits and preparing regulatory documentation for submission on the Plataforma Brasil.To avoid delays in the conduct of pharmacoeconomic studies, I structured the payment flow of fees for the Research Ethics Committees (CEP) for the conduct of studies and managed the financial control of health economics studies.I supported the review of data and information used in the tools and product portfolio for market access and sales force areas.I monitored decisions and evaluations of the incorporation of new health technologies by CONITEC.I provided support in the preparation of documentation for the drug pricing registration process at CMED.