Bárbara Do Lago F Da Silva Email & Phone Number

State Of São Paulo, Brazil

São Paulo, Brasil

- Acting as the Affiliate Functional Quality Representative for LATAM (Brazil, Argentina, Chile, Uruguay, Colombia, Mexico), Canada, Spain and Portugal in the Global Safety and Regulatory Science department.- Support the affiliates in the management of Quality Issues, deviations and the approval of root cause analysis, corrections, CAPA and effectiveness check in TrackWise. - Serves as subject matter expert to design, develop, deliver and improve programs and services in order to… Show more - Acting as the Affiliate Functional Quality Representative for LATAM (Brazil, Argentina, Chile, Uruguay, Colombia, Mexico), Canada, Spain and Portugal in the Global Safety and Regulatory Science department.- Support the affiliates in the management of Quality Issues, deviations and the approval of root cause analysis, corrections, CAPA and effectiveness check in TrackWise. - Serves as subject matter expert to design, develop, deliver and improve programs and services in order to optimize processes, behaviors, performance and audit readiness;- Accountable for assigned initiatives aimed at supporting and/or ensuring pharmacovigilance quality operational delivery via efficient and effective processes, associated systems, training and communications;- Review, assess and update pharmacovigilance procedural documents for overall compliance with current processes meeting internal and regulatory requirements;- Support the affiliates in the GVP audit/inspection readiness, during the audit/inspection in the control room reviewing the document requests and post-audit/inspection with the creation and management of CAPAs and actions for the findings.- Perform metrics reports for CAPAs, CAPAs actions, procedural periodic review and deviations. Show less

São Paulo, Brasil

- Responsible for the processing and quality check of spontaneous cases in Argus Safety Database (LAM) for Argentina and Chile;- Responsible for internal reconciliations with other departments for Argentina and Chile;- Responsible for the distribution of spontaneous and solicited cases for processing in Brazil;- Responsible for the submission of Medical Devices individual reports, besides investigative reports to the National Heath Authority;- Responsible for interacting with… Show more - Responsible for the processing and quality check of spontaneous cases in Argus Safety Database (LAM) for Argentina and Chile;- Responsible for internal reconciliations with other departments for Argentina and Chile;- Responsible for the distribution of spontaneous and solicited cases for processing in Brazil;- Responsible for the submission of Medical Devices individual reports, besides investigative reports to the National Heath Authority;- Responsible for interacting with the Quality Assurance department, attending periodic meetings, besides performing reconciliations;- Responsible for maintaining accurate KPIs/metrics regarding submission of ICSRs to Global PV and to the NHA, submission of aggregate reports to the NHA, CAPA and local team training compliance.Achievements: Elaboration of Argus (LAM) processing manual describing in detail Brazil Pharmacovigilance practices to accomplish the requirements on local and global policies.Participation in Colombia internal audit as backroom responsible person (Sep-2020) supporting Colombia’s LSOs in the collection and management of requested documents during the audit. Show less

São Paulo

- Performs the processing of ICSRs from solicited and spontaneous sources in Argus Safety Database (LAM); - Performs follow-up with the reporters to obtain additional information, according to client´s policies;- Periodic reconciliation of ICSRs with appropriate internal and external stakeholders in a timely manner and in compliance with procedures;- Submission of ICSRs to Regulatory Authority (CVS-SP and ANVISA, as applicable);- Case processing quality-check for accuracy and… Show more - Performs the processing of ICSRs from solicited and spontaneous sources in Argus Safety Database (LAM); - Performs follow-up with the reporters to obtain additional information, according to client´s policies;- Periodic reconciliation of ICSRs with appropriate internal and external stakeholders in a timely manner and in compliance with procedures;- Submission of ICSRs to Regulatory Authority (CVS-SP and ANVISA, as applicable);- Case processing quality-check for accuracy and internal compliance;- Interface with sponsor, vendors and other global PV personnel;Achievements: Participation in client’s internal audit in pre-audit requests and during the audit as backroom responsible person collecting all PV documents requested by the auditors, as well as requesting to other departments to send the documents requested within 24 hours (Dec-2019). The outcome of the audit was no finding to PV. Show less

Rio De Janeiro

- Mentoring and development of PV intern and junior analyst (direct reports);- Verification and monitoring of the metrics of late reports sent to the central Pharmacovigilance team (definition of root cause, corrective and preventive actions);- PV awareness project at the national level with Regulatory Authority and other Pharmaceuticals to disseminate the concept to HCPs;- Performing internal audits of local PV activities; - Development of local Standard Operating Procedures… Show more - Mentoring and development of PV intern and junior analyst (direct reports);- Verification and monitoring of the metrics of late reports sent to the central Pharmacovigilance team (definition of root cause, corrective and preventive actions);- PV awareness project at the national level with Regulatory Authority and other Pharmaceuticals to disseminate the concept to HCPs;- Performing internal audits of local PV activities; - Development of local Standard Operating Procedures (SOPs) and F2F training;- Overall experience with the pre-audit request for information and audit interviews (GSK L2 PV audit in 2013; GSK L2 PV audit in 2015; GSK L3 PV in 2016; GSK L2 PV in 2018);- PV Awareness Project to HCPs students (lectures at universities) and to the public (publication on Facebook);- Development of Study Pharmacovigilance Plan for Non-interventional studies to comply with GSK safety requirements according to study design;Achievements: Participation in external meetings (INTERFARMA and SINDUSFARMA) with other Pharmaceuticals to review clinical study local regulation and propose changes to Regulatory Authority to comply with ICH regulation. After the publication of RDC 09/2015, a gap analysis was performed to verify if the company was following every requirement.Participation in the ANVISA meeting in Brasília, together with other pharmaceutical companies, to discuss Pharmacovigilance requirements for Phase IV studies. Show less

Rio De Janeiro E Região, Brasil

- Submission of Periodic Safety Reports (DSUR) and Clinical Safety Documents (DILs/Investigator’s Brochure) to Regulatory Authority (ANVISA);- Processing of ICSRs from PMS (Patient Support Program), clinical and spontaneous sources in Argus Safety Database (LAM); - Assistance to CRAs and CSSs, as needed in relation to Pharmacovigilance activities in clinical studies;- Mentoring and development of PV interns (direct reports);- Review of Clinical Trials protocols, Safety… Show more - Submission of Periodic Safety Reports (DSUR) and Clinical Safety Documents (DILs/Investigator’s Brochure) to Regulatory Authority (ANVISA);- Processing of ICSRs from PMS (Patient Support Program), clinical and spontaneous sources in Argus Safety Database (LAM); - Assistance to CRAs and CSSs, as needed in relation to Pharmacovigilance activities in clinical studies;- Mentoring and development of PV interns (direct reports);- Review of Clinical Trials protocols, Safety Management Plans and Treatment Use Programs guidelines (Expanded Access Programs, Compassionate Use and Post-Study Provision) to ensure that the safety requirements are following local regulations;- Development of GSK/External HCP interaction projects: scientific stands in medical congresses and educative materials;Achievements: Responsible for the exchange process of the oncology portfolio with vaccines of Novartis. Active participation in meetings with pharmacovigilance staff of clinical research at Novartis to guarantee a robust and accurate database exchange.Gap Analysis was performed between local regulation, international regulation and company policies to verify every safety requirement. Show less

Rio De Janeiro E Região, Brasil

- Training of internal and external stakeholders about PV activities; - Doing follow-up with HCPs to obtain more information about spontaneous cases reported;- Submission of Individual Case Safety Reports to Regulatory Authority (ANVISA) following reportability criteria and deadline established in local regulations;

Rio De Janeiro E Região, Brasil

- Sending of safety reports (Investigator´s Brochure, INDSR, PSRI, DIL) to Investigators;-Management of safety reports submission to Ethics Committees by sites; - Clinical Research site training in PV activities.

Pós-Graduação, Business/Commerce, General

Farmacêutica, Farmácia