Beatriz Pozzane Email & Phone Number

São Paulo, Brasil

São Paulo, Brasil

São Paulo, São Paulo, Brasil

- Defining strategies for regulatory and ethics submissions in Brazil;- Preparation of clinical trial dossiers for Ethics Committee and Health Authority submissions in Brazil;- Identification and implementation of development needs and processes improvements;- Participation in trade association meetings (e.g. Interfarma and Sindusfarma) as well as support meetings with regulatory agencies- Support the training for less experienced Clinical Trials Regulatory analysts.- Responsible for preparing and managing the regulatory projections for Clinical Trials to be conducted in Brazil;

São Paulo E Região, Brasil

- Responsible for preparing and managing the regulatory projections for Clinical Trials to be conducted in Brazil;- Collabotation in defining strategies for regulatory submissions in Brazil;- Responsible for preparing all applicable documents for ethics submission to Local Ethics Committees and National Ethic Committee (CONEP);- Responsible for the preparation, submission and monitoring of Dossiers submitted to the local Health Authority (ANVISA);- Responsible for monitoring the Importation Process of the supplies for Clinical Trial to ensure that the supplies reaches the warehouse in a timely manner;- Receiving, sorting and distributing safety reports relevant to Clinical Trials conducted locally;- Responsible for preparing presentations and training related to regulatory subjects;- Coordinating the hand-over of initiated Clinical Trials to monitors and project managers;- Responsible for archiving and organizing the electronic file of regulatory documents;- Active participation in external meetings with Brazilian regulatory/Ethics Authorities, Competitors and Professional Class Associations (e.g. Interfarma and Sindusfarma) to exchange experiences and information;- Responsible for supportting the training for less experienced Clinical Trials Regulatory analysts;- Support the identification of development needs and processes improvements.- Responsible for implementing new systems for start-up area.

São Paulo E Região, Brasil

- Responsible for preparing all regulatory documentation to be submitted to the Local Ethics Committees (CEPs) and National Ethic Committee (CONEP);- Responsible for the preparation, submission and monitoring of Dossiers submitted to the local Health Authority (ANVISA);- Responsible for monitoring the Importation Process for Clinical Trials and for giving support to Clinical Supplies Coordination and Shipping departments;- Receiving and sorting of safety reports relevant to Clinical Trials conducted locally;- Giving support for the development and improvements of internal process.

Brasil

- Responsible for reviewing and coordinating local EC submissions in alignment with global submission strategy;- Experience in preparation of local MoH submissions, as applicable in alignment with global submission strategy;- Coordinating, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; - Experience in preparing sites specific Patient Information Sheet/Informed Consent form documents. - Direct contact with investigators for submission related activities or act as a key-contact at country level for either Ethical or Regulatory submission-related activities;- Responsible for preparing the regulatory compliance review packages;- Responsible for providing general office management to keep operations running smoothly;- Accountable for meeting applicable project timelines in accordance with the master contract;- Working with multiple sponsors and sites simultaneously; - Assisting with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol.

São Paulo

- Performed and coordinated assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to achieve the safety and efficacy of investigational products and/or medical devices;- Acted as the main line of communication between the sponsor and the investigator;- Developed collaborative relationships with investigative sites and client company personnel;- Reviewed regulatory documents for proper content in accordance with FDA, ICH/GCPs, PPD and client company appropriate SOPs prior to submission to the Project Manager, Central IRB, regulatory Affairs and/or the client;- Performed PPD file reviews in a timely manner.

São Paulo E Região, Brasil

Study Coordinator Trainee: Supporting study coordinator activities. Performed and coordinated assigned aspects of the clinical studies process in accordance with the protocols, GCPs and SOPs. Supporting study coordinator for Phase III clinical trials in Kidney Transpant indications.

São Paulo E Região, Brasil

- Revision of established products manuals;- Analyzes and answer questions regarding the company's products;- Provide support to customers by scientific assistance;- Pharmacovigilance;- Pharmaceutical Care.- Standardization of SAC activities.- Participation in hypertension, cardiology, pharmacovigilance and medical sales training provided by the company.

Postgraduate, Biotechnology

Biofuels , Environment and Agribusiness , Food and Biopharmaceuticals

Bachelor Of Pharmacy (B.Pharm.), Health/Health Care Administration/Management