Clinical Research, PVG, Regulatory affairs, Start Up and BD

ESTELA REGINA VACARI PINTAO

Av. Santa Marina, ***8 - ap.83 - torre 3 DoB: 13-Dec-1981

São Paulo - SP - Brasil - CEP: 05036-001 CRF-SP: 39.757

Phone: 55-11-982****** (mobile) E-mail: **********@*****.***.**

Objective: Clinical Research

Professional Experience

Company: Intrials Latin America Clinical Research

Period: May/2012 to Mar/2014

Position: Lead Start Up LATAM

• Verify the feasibility of conducting a clinical research project in Latin America countries;

• Linking between the sponsor of the study and the departments and affiliates of Intrials;

• Identification of potential investigational sites to conduct clinical research;

• Site Selection for clinical trials;

• Perform Site Qualification Visits at potential sites;

• Selection of Coordinator site and Preparation of Regulatory dossier;

• Negotiation and execution of CTAs and budgets with investigational sites and sponsor;

• Preparation and review of proposals to customers;

• Official scientific data searches for inclusion in proposals;

• Monitoring and training of business activities to the affiliates in Latin America;

Company: Biolab Sanus Farmacêutica

Period: February/2010 to May/2012

Position: Safety Specialist

• Analysis, review and classification of adverse event reports

• Causality analysis and MedDra classification of adverse events

• Preparation of PSURs, Pharmacovigilance Plans and Risk Minimization Plan

• Preparation and ministration of staff trainings

• Preparation of CIOMS reports

• Submission of adverse events from Clinical Research and post-marketing products to Regulatory Authorities

• Elaboration and review of SOPs

Company: Biolab Sanus Farmacêutica

Period: October/2009 to January/2010

Position: Clinical Research Associate

• Conduction of Monitoring and Close out visits of clinical trials (Phase II, III and IV).

• Preparation of Regulatory Dossiers (Submissions to ANVISA - CONEP)

• Clinical trials Audits

• SAEs Reports to ANVISA (Brazilian MoH)

• Preparation of final reports from clinical research sites

• Preparation and submission of sponsor final reports to ANVISA

• Pharmacovigilance training to Clinical Research team

Company: PPD Inc.

Period: July/2007 to September/2009

Position: Clinical Research Associate

• Conduction of Selection, Initiation and Monitoring visits of multicenter trials (Phase I to IV).

• Participation on Regulatory Processes (Submissions to ANVISA - CONEP)

• Sponsor and Sites legal contracts and Inspections of sites in multicenter trials.

• Preparation and review of site Initiation and study files.

• Conduct Site Feasibilities.

• Preparation and review of Regulatory Packages.

• Review of corporate legal documents to elaboration of legal contracts and Site CTA negotiations.

Company: TOXICLIN – SOLUÇÕES EM TOXICOLOGIA

Period: August/2002 to July/2007

Position: Coordinator of Poisoning Emergency and Pharmacovigilance.

• Coordinator of Emergency treatment for poisoning, Cosmetic and Pharmacovigilance Department.

• Consulting in Toxicology, Transportation of hazardous materials, MSDS (Material Safety Data Sheet).

• Responsible for risk evaluation of chemical products to human health.

• Responsible for hiring, training and supervision of trainees.

Company: CCAA

Period: May/1999 to July/2003

Position: English Teacher - Groups of Beginners to Advanced

Education

• Clinical Pharmacology Specialist, 2013 Faculdades Oswaldo Cruz, São Paulo, SP, Brazil

• Pharmacy and Biochemistry, 2005 - Faculdades Oswaldo Cruz, São Paulo, SP, Brazil

Languages

English – Fluent

Spanish – Advanced

Professional Development

Course: GCP atualization – Feb/2014

Course: Brazilian Regulatory Legislation Updates – Feb/2014

Course: Spiritual Leadership – Feb/2013

Course: Cosmetovigilance – Mar/2012

Course: Pharmacovigilance: Practical Analysis of four Safety Managing Problems – Jul/2011

Course: Pharmacovigilance: Signal Detection – Mar/2011

Course: Pharmacovigilance: Practical applications of the Guides from RDC 04/2009 - Nov/2010.

Mini Course: Drug Interactions – Sep/2010.

Course: Atualizations in Regulatory Affairs – Aug/2010.

Course: Tecnovigilance and Risk Management – Aug/2010.

Workshop: Pharmacovigilance Inspections (ANVISA + FDA / MHRA) – Jun/2010.

Course: Pharmacovigilance ministered by CVS-SP director – Feb/Mar 2010.

I Seminary of Clinical Research - New Brazilian Regulations - Sep/2009.

Foundation Program – PPD Inc. Wilmington, USA – 2008 (80 hours)

Regulatory Affairs Course at Faculdades Oswaldo Cruz - 2004.

Specific knowledge

• Word, Excel, PowerPoint, Access, Oracle

• Regulations of Latin America for Clinical Research and Pharmacovigilance

• GCP - ICH and Quality Assurance Inspections and Processes

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