Anahi Torres Email & Phone Number

- Managed pharmacovigilance cases through documentation, and case processing of AEs, SAEs, and AESIs.- Novavax accreditation: Completion of processing and assessing post-marketing case forms specific to COVID-19 vaccines, inclusive of applicable Investigator Studies or registries, received by ProPharmaGroup on behalf of Novavax.- MedWatch/CIOMS/E2B Preparation: Composed case narratives and reviewed reports in accordance with internal guidelines, Data Entry Manual, SOPs, WIs, regulatory authorities, and safety partners worldwide.- Captured patient medical and social history, demographics, lab data, and concomitant medications in Oracle Argus database.- Processed ICSRs for regulatory reporting, and manipulated datasets in Argus using MedDRA coding and WHO drug.

-ICH GCP E6 R (2)-Clinical Trial Operations from feasibility through close-out.-FDA Regulations 21CFR 11, 50, 54, 56 and the Common Rule 45CFR46.-Identification and reporting of AE and SAE.-Comprehension and Execution of Clinical Trial Protocols. -Data Management. -GDP following ALCOA-C principles.-Maintaining a regulatory binder, housing essential documents, including but not limited to- 1572, DOA, Training Logs, and other Investigator Site File (ISF) document.-Quality Assurance, Monitoring, and Query Resolution.

Marietta, Georgia, United States

- Initiated contact with potential donors, provided education, and guidance on the donor placental process. - Obtained informed consent, and determined donor suitability for allograft transplantation based on approved guidelines. - Coordinated the daily recovery of human birth tissue and ensured sterile handling.- Conducted medical and social questionnaires, chart reviews, and follow-ups using GMP, GCP, and GDP documentation.- Compliance with FDA regulations, HIPAA, State/Federal regulations, AATB standards, SOPs, WIs, and Quality Assurance.- Experience with onboarding new hires.- Facilitated and collected donor blood specimens for analysis/testing and tissue cell culturing by sterile technique.- Ensured proper labeling and identification were maintained on quarantined tissue containers for placental transportation.

Atlanta, Georgia, United States

- Laboratory Proficiencies (performing and interpreting): DNA/RNA purification, Chromosomal Isolation, Conjugation, Gel Electrophoresis, Ligation and Transformation, PCR, Plasmid Isolation, Restriction Digest, Serial Dilutions, Streak Technique, Gram Staining, Negative Staining, ELISA, Microscopy, UV Spectrophotometry, Western Blotting, Pipetting, Titrations, Preparing Media, Inoculation, Mutagenesis.- Computer Proficiency: CITI training, CLC Main Workbench, NCBI, Saner Sequencing, Tableau, R, Microsoft Office Suite (Excel, Word, PowerPoint, OneNote)