Julieta Belen Barrera

• Coordinates workflow to ensure delivery of project distributing and monitoring team workload managing a small team within the project.
• Provides support to manage safety and pharmacovigilance project risks/ issues as required: quality review of ICSRs, work performed by peers. Expert in SPVG, which includes resolution of project related routine queries, mentoring, and coaching.
• Improved customer satisfaction rates through proactive problem-solving and efficient complaint resolution.
• Followed Standard Operating Procedures (SOPs) and project/program specific safety plans to deliver quality work.
• Conducted regular reviews of operations and identified areas for improvement.
• Generated reports detailing findings and recommendations.

• Performed all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR), adhering to all data privacy guidelines, Good Clinical Practices (GCPs), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures for clinical trials and/or post-marketing safety programs.
• Participated in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
• Coordinated with data management staff concerning reconciliation of safety data between the clinical and safety databases.
• Ensured distribution of all required individual expedited and periodic reports for both clinical and post
• Maintained understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process.

• Responsible for managing the workload in the respective workflow ensuring equal distribution of cases/email communication between team members alongside meeting daily/weekly/monthly client deliverables.
• Run reports including AE/PQC reports and AE/PQC metrics when needed.
• Certify new Quality Controllers (QCers) and new joiners.
• Provide trainings and updates.
• Notify Key Performance Indicators (KPIs), investigate root causes and take corrective action when KPIs are not met.

• Responsible for reviewing, assessing and processing Lifecycle Safety data and information, across all service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team members.
• Redaction of source document personal identifiable information and attachment to case. Review and data entry of specified fields in database.
• Case follow-up. Reconciliation of cases against regulatory listings, Safety Data Exchange Agreement (SDEA) mailbox, etc as needed. Monitors the workflow of phone, email and postal Follow Ups (FUPs) in Argus.

Thesis work "treatment of tumor heterogeneity with oncolytic viruses transcriptionally directed with hybrid and synthetic promoters"

• Managed social media channels effectively for improved brand visibility and increased audience interaction.
• Collaborated with cross-functional teams, optimizing marketing initiatives that supported community growth.
• Increased membership retention rates by developing targeted campaigns aimed at re-engaging inactive users.

• Learned multiple molecular biological techniques.
• Managed specimen sample handling, receiving, storage and inventory.
• Demonstrated flexibility in adapting to changing priorities or new assignments as needed within the lab environment.
• Enhanced laboratory efficiency by maintaining and organizing equipment, supplies, and samples.
• Safely prepared reagents, compounds and lab test solutions.
• Analyzed data to create and organize graphs, charts and documents for publications and presentation.
• Conducted DNA, RNA and protein extraction and quantification using spectrophotometer and gel electrophoresis.
• Contributed to the successful completion of research projects by effectively managing time, resources, and workload while maintaining a high level of quality control.

• Maintained daily report documents, memos and invoices.
• Handled sensitive information discreetly, maintaining confidentiality when managing personnel files or financial data.
• Created and updated records and files to maintain document compliance.
• Answered multi-line phone system and enthusiastically greeted callers.
• Composed business correspondence and official documents to assist accounting staff.
• Organized office systems to maximize efficiency and completeness of records.