Fernanda Boromello A. Alves

Experience

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  Laboratorio Farmaervas

  Jan 2008 - Jan 2009

  Microbiological and Physical-Chemical Laboratory Analyst

  - Activities related to physical-chemical and microbiological quality control of cosmetic products.- General analyzes of finished products, intermediates and raw materials and production water.- Knowledge in Good Laboratory Practices and Standard Operating Procedure.- Verification of all stocked raw materials for proper labeling and storage.- Control of laboratory material, such as input, output and stock.- Participation in the validation process of cleaning, process and analytical methods.- Selection and control of suppliers.- Emission of results of materials submitted to tests and trials, detailing technical specifications.- Training and microbiological inspection at the factory. Show less

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  Pfizer

  Jul 2009 - Dec 2018

  - Processing of adverse event reports, from receipt, triage, evaluation and monitoring (from “prioritization” to “distribution”), including reports of clinical research, legal and licensed products.- Submission of adverse event reports to CVS and ANVISA.- Activities related to the submission of (SUSAR) to ethics committees and clinical trial investigators.- Responsible for monitoring and coordinating scientific literature activities, including weekly review of chosen journals; selection and annual evaluation of scientific journals for review; annual update of local standard operating procedure for literature; training and monitoring of colleagues in the activity.- Elaboration, analysis and compilation of the monthly performance report (Performance PCO/DSU report).- Implementation of corrective and preventive actions (CAPAs) after reviewing several quality reports prepared by the headquarters.- Support in the elaboration of local procedures, as well as in the study of updates in global procedures.- Participation in teleconferences and forums with the global Pharmacovigilance team, as well as contact with headquarters in resolving questions about adverse event reports and Pharmacovigilance processes.- Participation in internal audits and regulatory inspections.- Participation in feedback meetings with employees, as well as support in Objectives and PDI (Individual Development Plan) issues, assisting colleagues in personal and professional development and helping to engage the department.- Responsible for managing the daily flow of pharmacovigilance, allocating colleagues in different activities, in order to ensure the finalization and submission of reports of adverse events to the headquarters;- Training and follow-up of new colleagues in Pharmacovigilance. Show less - Processing of adverse event reports in the Argus system, including receipt, screening, evaluation and monitoring of adverse event reports.- Conducting follow-up activities with consumers and health professionals.- Submission of reports to CVS and ANVISA.- Processing reports of adverse events from clinical studies and contact with monitors and research centers.- Compliance with the specific legislation in force, to maintain the regularization of the company's operations in relation to pharmacovigilance requirements.- Development of colleagues in relation to the company's culture and aspects related to pharmacovigilance.- Participation in worksharing with other countries (eg China), including processing reports for other countries.- Preparation of documents for internal audits and regulatory inspections.- Participation in Pfizer's engagement survey, including the creation of an action plan and contribution to the department's improvement and problem solving.- Responsible for all pharmacovigilance flow during long holidays.- Interface with other departments (Medical Information, Quality, Medical Affairs).- Participation in the Yellow Belt Course. Show less - Processing of adverse event reports in the Argus system, including triage, evaluation and monitoring of reports.- Conducting follow-up activities with consumers and health professionals.- Maintenance and control of Pharmacovigilance activities, including file of forms and documents.- Preparation of documents for internal audits and regulatory inspections.- Participation in Pfizer's engagement survey, including the creation of an action plan and contribution to the department's improvement and problem solving.- Creation of a committee to study local procedures in order to identify the team's problems and difficulties and facilitate the understanding of activities, as well as improve the quality of reports.- Participation in local pharmacovigilance meetings. Show less

  • Senior Pharmacovigilance Analyst

    Oct 2016 - Dec 2018

  • Pharmacovigilance Analyst

    May 2014 - Oct 2016

  • Junior Pharmacovigilance Analyst

    Sept 2010 - Apr 2014

  • Pharmacovigilance Assistant

    Jul 2009 - Sept 2010
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  PRA Health Sciences

  Dec 2018 - Apr 2021

  Drug Safety Coordinator

  - Coordination of Adverse Event Report Processing tasks in a HUB with 18 analysts and 2 interns- Distribution and assignment of tasks and responsibilities in the team.- Elaboration of task control dashboards.- Monitoring the performance and compliance of the team and preparing reports for the client.- Projection and Demand Management.- Involvement in the process of recruiting new colleagues.- Active participation in the preparation and attendance to internal audits and regulatory inspection, including support to customer audits.- Responsible for developing local procedures and training for the team.- Responsible for the control and compliance of the team's training.- Support in the implementation of Pharmacovigilance HUBs in Latin America.- Team Engagement and Motivation. Show less

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  ICON Strategic Solutions

  Apr 2021 - Aug 2023

  I monitored the project to ensure the company's profitability and the fulfillment of the goals and objectives of the associated project. I actively participated in the development, implementation and monitoring of profitability, objectives, metrics of the group assigned to the 19 direct reports. Identification and implementation of process improvements through periodic project review. Resource management and resource projections to ensure project teams are consistent with customer needs and expectations and contractual obligations. Technical alignment with the team to carry out critical operational tasks in order to achieve results and conduct training on topics related to the pharmacovigilance department, as well as general company processes and systems for the team. Responsible by reviewing project tasks and delegating service deliverables to the customer. Responsible by ensuring staff fulfill their responsibilities in accordance with contract and company and/or client quality standards, policies, procedures and SOPs, as applicable. I created an environment that encourages learning, self-improvement and career development for direct reports. I performed metrics collection and data analysis to support the company's efforts for continuous improvement in policies, procedures and business processes. I developed team employees to ensure high quality work performance and high quality employee retention and ensure that team development and performance feedback is provided through activities such as mentoring and career development. Communicated team/individual goals and expectations to ensure direct reports understand their responsibilities. I participated in the recruitment processes of new employees for the team. I attended client meetings as needed. Preparation and conduction audits and inspections. Show less

  • Manager of Drug Safety Center

    Jul 2021 - Aug 2023

  • Drug Safety manager

    Apr 2021 - Aug 2023
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  Johnson & Johnson Innovative Medicine Brasil

  Aug 2023 - now

  Gerente de farmacovigilância/Local Safety Officer