Bárbara Castro Email and Phone Number
I am a Polyglot (Portuguese, English, Spanish and French) cross-cultural Pharmacist with over 10 years of experience in the Pharmacy field. Those include Medical Information Officer, Pharmacovigilance (Patient Safety) in Latin America and more than 07 years of experience monitoring of high-risk business activities as Quality Assurance and Healthcare Ethics and Compliance Officer (HECO) acting as a leader for Regulatory implementation inputs and data in accordance with local and international guidelines as well as adaptation of the business with a focus on LGPD (Brazilian general data protection law) for post-marketing (Market Research) business. Reviewing and approvals of HCPs and Patient Related activities.Implementation of standard operating procedures as well as Business Maturity Assessment. Deep knowledge in Healthcare Compliance for Market Research business promoting a culture of integrity, where employees are encouraged to speak up about ethics and compliance issues and concerns, providing ECO awareness and Code of Conduct training during/ onboarding of new employees as appropriate. Keeping a high attention to details, able to critically think and effectively bring outstanding results on the projects and high sense of urgency to manage priorities. I believe my previous experiences have taught me how to implement a consistent standard procedure in regional level focused on pharmaceutical needs and compliance metrics achieving excellence, high understanding of Medical Information in national and international level becoming be results-driven, a team player as well as how to adapt easily to a changing environment.
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Data Management And Governance LeadRoche Dec 2022 - PresentEnsuring that Data Owners are identified and that the data used is valid, reliable, traceable, timely, available, secure and consistent; Contributing to the evolution of the data governance program;• Define roles and responsibilities related to data governance and ensure clear accountability for managing the company's key information assets;• Definition of performance indicators and quality metrics and ensure compliance with policies, standards, roles and responsibilities related to data and adoption requirements;• Contribution to gaining knowledge in the context of the business and unifying the vision of data in the company;• Supporting Roche's Compliance program on Data and Analytics issues, interacting with the DPO (Data Protection Officer) and Security areas;• Development and maintainance of processes aimed at protecting/controlling the use of data in the company;• Supporting the implementation of data governance policies and processes, always in line with the Company's strategy. in relation to its data processes;• Demanding improvements in quality and monitoring components, ensuring evolution and continuous improvement;• Supporting in the definition of standards and strategies for data quality and the implementation of good data governance practices based on the best practices of market models, such as DMBoK. -
Risk Intelligence And Management Champion - Latin AmericaRoche Jun 2023 - Mar 2024LATAM PL Risk Management SME/Champion
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Assoc Director - Medical Information And Quality Mgmnt - Latin AmericaIqvia May 2022 - Dec 2022structuring of business units with regard to quality processes, compliance, local regulations linked to the availability of information to other areas of the company.Leader in global initiatives for implementation in other countries with support from the local team as well as crucial areas of business strategy. Leader in local and regional audits focused on Medical Information - Post Marketing, Consulting, Market Research, Sales Force. -
Healthcare Ethics And Compliance OfficerIqvia Aug 2020 - Dec 2022Point of contact and resource for local HCC and ABAC compliance related questions and guidance; Promote a culture of integrity, where employees are encouraged to speak up about ethics and compliance issues and concerns;Provide ECO awareness and Code of Conduct training during onbording of new employees as appropriate.
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Regional Healthcare Compliance And Patient Safety ManagerIqvia Aug 2020 - May 2022São Paulo, Brasil• Contributing to the development, and supports implementation of the Quality Management Plan within the scope of the assignment; this include: Planning and executing the Quality Management activities. Risk identification and assessment through data review and quality control processes. • Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement. • Supporting the assigned business line management and staff to enhance effectiveness in project delivery.;• Cooperating closely with the relevant business lines and other stakeholders, support maintaining focus on quality in project delivery.• Providing advice and support to teams within the assigned business line on all aspects of Good Pharmacovigilance Practice (GVP) compliance.• Working in close cooperation with teams to manage non-compliance, quality issues assist in planning corrective/preventive actions, as applicable according to Standard Operating Procedures (SOPs).• Providing assistance during audits and regulatory inspections to the teams to the extent agreed with the line manager and as required by the applicable SOPs.• Acting as the primary contact for Quality Assurance on quality matters – on the level of the assignment, attend meetings/teleconferences.• Preparing periodic reports to business lines on quality related matters, risk assessments and specific quality improvement initiatives.
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Compliance Officer And Patient Safety Coordinator (Latin America)Iqvia Dec 2017 - Aug 2020São Paulo• Audit Handling: Working with internal and external counsels, consultants, and the management team to handle internal and external audits for areas such as Quality Management System, Affirmative Action, and HIPAA Security Risk Assessments.• Identify and Resolve Compliance Issues: Performing gap analyses and identify what the company needs to do to come into compliance where a gap is found. For any gaps in compliance, plan and implementation of any needed change.• Policies and Procedures Handling: Working with the heads of each relevant department to review, draft, and implement policies and procedures related to areas such as employment and privacy and security;• Identification of potential risks and non-compliance in daily business activities for proper addressing and remediation. Developing and implementation of remediation actions• Provide guidelines on the relevant Ethics & Compliance principles, standards and regulations • Maintaining documentation relevant to Ethics & Compliance activities• Responsibilities of safety / management project leader endpoints for projects that require a team of Pharmacovigilance, including but not limited to: (a) Allocation of schedule; b) decision making for the project. c) Proactive communication for management of new problems and suggested solutions; and reports to take on new responsibilities. (d) Development and review of project proposals, budgets, agreements, invoices, financial and legal measures. e) Elaboration of a Security Management.
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Compliance Champion And Drug Safety Coordinator - BrazilIpsos Brasil Jun 2015 - Dec 2017- Structuring of the Pharmacovigilance department for the Market Research segment.- People management- Preparation of internal procedures together with the Department of Quality and Corporate Governance in order to fulfill obligations of regulatory bodies (ANVISA) and ISO- Training of internal and external collaborators (suppliers).- Identification, collection and notification of adverse events (spontaneous and requested).- Reports to customers.- Participation in results presentation meetings in order to corroborate the adverse events collected during the research.
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Drug Safety AssociateSense Company. Oct 2013 - Jun 2015Rua Henri Dunant, 1.383Analyst of local Pharmacovigilance in Market Research.
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Drug Safety AssociateResulta Serviços De Inteligência De Mercado Oct 2013 - Jan 2015
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Control And Quality Assurance InternRocha Farma Dec 2012 - May 2013Elaboration of SOP (standard operating procedure), phytochemical analysis of raw material, issuance of reports.
Bárbara Castro Skills
Bárbara Castro Education Details
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Data Science And Analytics -
Auditing I: Conceptual Foundations Of Auditing -
Ministry Of Health - Primary Attention For ImmunizationPharmacy -
Pharmaceutical Marketing -
Pharmarcy -
Quality Assurance
Frequently Asked Questions about Bárbara Castro
What company does Bárbara Castro work for?
Bárbara Castro works for Roche
What is Bárbara Castro's role at the current company?
Bárbara Castro's current role is Medical Information | Data Governance | Quality Management | OpenHealth | Data Science | Risk Intelligence.
What schools did Bárbara Castro attend?
Bárbara Castro attended Usp - Universidade De São Paulo, University Of Illinois Urbana-Champaign, Ministry Of Health - Primary Attention For Immunization, Faculdades Oswaldo Cruz, Faculdades Metropolitanas Unidas, Faculdades Metropolitanas Unidas.
What are some of Bárbara Castro's interests?
Bárbara Castro has interest in Social Services, Children, Civil Rights And Social Action, Environment, Poverty Alleviation, Disaster And Humanitarian Relief, Animal Welfare, Health.
What skills is Bárbara Castro known for?
Bárbara Castro has skills like Pesquisa, Microsoft Powerpoint, Atendimento Ao Cliente, Market Research, Pharmacovigilance, Business Analysis, Pharmaceutical Industry, Quantitative Research, Microsoft Excel, Microsoft Word, Pesquisa De Mercado, Pesquisas De Mercado.
Who are Bárbara Castro's colleagues?
Bárbara Castro's colleagues are Sheela Bisht, Alain Lhuillier, Thomas Schindler, Paola Andrea Hernandez Montes, Maria-Theresia Rose, Olesya Semivrazhskaya, 張玉承.
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