Vinicius Amaral Email and Phone Number
Undergraduate at UNESP-Araraquara in Pharmacy - Biochemistry, during college, I have participated in many extents, research, and learning projects. Related to that, I took part in Student Council, and also I was part of Curso Unificado do Campus Araraquara (CUCA) as a Chemistry teacher. While in research I was able to conduct research on the effect of Roux-en-Y bariatric surgery on the pharmacokinetic parameters of drugs. A literature review for Roux en Y gastric bypass (RGYB) where I assessed drug pharmacokinetics after RGYB and also evaluate a new procedure to predict the Physiologically based pharmacokinetic modeling.As a professional experience, I had the opportunity to work in the quality area at Medley Sanofi, after which I was part of the regulatory team at Eli Lilly do Brasil. Later, I moved to clinical research in the preparation of the submission of regulatory and ethical dossiers both for start-up and for the maintenance of studies until their close-out, I worked for 2 years in the PPD in FSP model and at the moment I am at IQVIA performing the same function, but also providing support to other analysts.I'm an extrovert person and I have a high ability to express myself in public and convey knowledge in a simple way. Besides, I have a facility for computerized environments and technologies focused on healthcare. I managed to master the systems that I need to use on a daily basis, in terms of hard skills, I have knowledge of Veeva RIM and eTMF and I have already been the Sponsor's point of contact for the Veeva RIM system.
-
Country Site Activation LeadIqviaState Of São Paulo, Brazil -
Country Site Activation LeadIqvia Jan 2024 - PresentSao Paulo- Primary contact for the study in which I am assigned in the country;- Interface with the global management teams as Project Manager, Clinical Lead and with the local team as Site Solutions Manager;- Creation of tools to improve the local team's routine;- Submission strategy for new projects under new law for Brazil;- Active participation in reviewing documentation for activating sites in Brazil;- Review of ethical and regulatory dossiers;- Multi-sponsor facing -
Senior Site Activation SpecialistIqvia Mar 2023 - Jan 2024São Paulo, Brasil- Senior Point of Contact/ Primary contact for Clinical Study- Support Specialist with Regulatory expertise- Study start-up management (Site and Country level)- Quality Check of submission packages from ANVISA and EC- Develop new strategies for Study Start-up management -
Country Approval SpecialistPpd Dec 2021 - Mar 2023São Paulo, Brazil- Submission strategy for new studies allocated in Brazil;- ANVISA (HA) Submissions, IRB/IEC submissions- Management of Veeva RIM/RPS submissions and set up the milestone for the IP import process;- Conduct meetings with the customs broker to speed up/facilitate the import process.- Regulatory risk assessments for clinical trial and Kick-off meetings for the feasibility of study;- Support to the project managers team, centers, clinical team, and regulatory team;- Interaction with the Global CMC team to provide support to our submission.- Quality reviewer for ABAC (Anti-Bribery and Corruption Program) for CTA firmed with Research Sites. -
Clinical Trial CoordinatorPpd Jan 2021 - Nov 2021São Paulo, BrazilRegulatory startup coordinatorANVISA: Submission DCDD and Dossier study specific, substantial amendments and non-substantial, DSUR, proactive communication with Brazil RA (ANVISA) IRB/IEC: Initial submission of ethic dossier, amendments to Brazil plataform's, notifications, submission follow up with study center, communication with Central team to documents being in comply with Brazil Legislation. -
Regulatory Affairs InternEli Lilly And Company Jun 2019 - Jan 2021São Paulo Area, Brazil- Regulatory intelligence related to diabetes products;- Preparation of dossier for submission to ANVISA/ SVS/ COVISA for both post-approval and others sporadic submission;- Know global best practices as well ICH guideline for submission;- Update Labelling: patient and Health Care Professional Literature, as well immediate label and label;- Be aware of new legislation and how it impacts Brazil and globally;- Keep Labelling accurate and contemporaneous for Brazil market- Provide data for another department like Marketing, Quality Assurance, Supply Chan and Drug access -
Quality Operations InternMedley Indústria Farmacêutica Oct 2018 - May 2019Campinas- Daily report of pharmaceutical products related to physical-chemical aspects- Understanding of pharmacopoeias for conducting analyzes- Handling equipment such as dissolvers, HPLC and spectrophotometer -
Chemistry TeacherCursinho Unificado Do Campus De Araraquara Aug 2015 - Jul 2018São Carlos Area, BrazilThe CUCA is a project for the community economically and socially needy at Araraquara and region.During the project, I acted as a chemistry teacher, whose I was responsible for planning and given lessons, prepare tests, data tabulation and disclosure of project on public schools.
Vinicius Amaral Skills
Vinicius Amaral Education Details
Frequently Asked Questions about Vinicius Amaral
What company does Vinicius Amaral work for?
Vinicius Amaral works for Iqvia
What is Vinicius Amaral's role at the current company?
Vinicius Amaral's current role is Country Site Activation Lead.
What schools did Vinicius Amaral attend?
Vinicius Amaral attended Universidade Estadual Paulista Júlio De Mesquita Filho, Federal Institute Of Education, Science And Tecnology Of Sao Paulo.
What are some of Vinicius Amaral's interests?
Vinicius Amaral has interest in Desenho E Projetos, Viagens Internacionais, Astronomia, Vôlei, Nanotecnologia, Tecnologia.
What skills is Vinicius Amaral known for?
Vinicius Amaral has skills like Desenhista Mecanico, Projetista, Tecnico Em Mecanica.
Who are Vinicius Amaral's colleagues?
Vinicius Amaral's colleagues are Eliana Cristina Galtarossa, Puja Shekhawat, Raja T S, Asya Koleva, Prabhudatta Tripathy, Macey Williamson, Mph, Zheng Wu.
Not the Vinicius Amaral you were looking for?
-
-
-
Vinicius Amaral
Software Developer @ Americanas S.A | Typescript | React | Nextjs | Nodejs | AngularVitória Da Conquista, Ba -
Vinicius Amaral
Administrador|Comércio Exterior|Empreededor|Liderança|Sou O Ceo Da Animalesko, Um Projeto Que Sou Imensamente Apaixonado E Realizado. 🥰🐶❤️Osasco, Sp
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial