Venkat Yanamandra, PharmD, RPh
Kendall Park,NJ
Summary
Analytical thinker and Pharmacovigilance Scientist who possesses extensive knowledge in clinical research and adverse event reporting. My four-year career spans clinical trial management, monitoring, project oversight, safety surveillance, protocol development, data analysis within safety database systems and interpretation of complex medical-scientific data. Committed to ensuring regulatory compliance and adept in understanding team priorities and delivering results independently. Known for adaptability, creativity, and results-oriented mindset. Committed to making meaningful contributions and advancing organizational goals. I am a motivated and enthusiastic individual and seek to leverage and build upon my experience with CROs and academia to significantly contribute to a biopharmaceutical manufacturer. Flexible, with the ability to work onsite as needed.
Overview
6
6
years of professional experience
Work History
Pharmacovigilance Scientist and Quality Manager - Oncology Cell and Gene Therapy
Gates Institute, University of Colorado
04.2023 - 02.2024
- Quality Improvement and Compliance: Led development of 20 Standard Operating Procedures (SOP) across multiple departments, enhancing efficiency of pharmacovigilance processes through the development and implementation of workflow improvements.
- Medical Writing and Quality Assurance: Assisted in preparing safety-related sections of clinical study protocols, ensuring that potential risks were adequately addressed from the outset of each trial.
- Patient Safety Management: Led product-level safety meetings, shared critical updates from Principal Investigators, evaluated potential safety signals for three oncology products in three First In Human (FIH) high-risk oncology trials, and produced detailed safety minutes for medical directors and regulatory authorities
- Patient Eligibility Assessments: Meticulously evaluated eligibility of new trial patient's medical record with Inclusion/Exclusion criteria of the protocol, and collaborated with medical directors to confirm patient suitability for diagnostic biomarkers and critical procedures including apheresis and CAR-T infusion
- Data Integrity and Compliance: Ensured data integrity with meticulous review and verification of case report forms in clinical trials.
- Data Compilation and Analysis: Aggregated and analyze patient data from safety databases and calls, contributing to creating Kaplan Meier Curves and Progression-Free Survival graphs for the SMC and vendor evaluations
- Advanced Data Analysis and Reporting: Conducted in-depth analysis of AE/SAE data for Safety Monitoring Committee (SMC) reporting across four clinical studies
- Safety Data Monitoring: Served as a safety data lead for four Phase One CAR-T clinical studies in EDC resulting in the creation of a safety management plan (SMP) utilized for identifying safety signals and mitigation
- Dose Limiting Toxicities (DLT): Investigated lab trends to identify and provide key insights to medical directors and regulatory strategists in Protocol Review Committee (PRC) for crucial dose decisions
- SAE Evaluation and Adjudication: Evaluated and adjudicated SAEs, determined their fit for medical monitoring based on Suspected Unexpected Serious Adverse Reactions (SUSAR) criteria
- Long-Term Follow-Up Monitoring: Efficiently managed Long Term Follow-Up Studies, vigilantly assessed Adverse Events of Special Interest in compliance with FDA guidelines
- Developed strategies for effective communication with external stakeholders, such as healthcare professionals and patient advocacy groups, ensuring clear understanding of product risks and benefits.
Clinical Research Associate - Vaccines
International AIDS Vaccines Initiative
10.2021 - 01.2023
- Clinical Trial Oversight: Strategically directed safety monitoring and site management for eight sites across four pivotal Phase I vaccine studies, ensuring protocol adherence, data integrity, and seamless study progression across diverse international locations
- Compliance and Quality Management: Spearheaded compliance initiatives, effectively identified and resolved critical compliance issues
- Implemented innovative strategies for monitoring biomarkers, safety trends and enhancing overall study quality
- Protocol and Regulatory Excellence: Championed strict adherence to protocols, FDA, ICH, and GCP guidelines across multiple studies, ensuring efficient and accurate data collection for comprehensive efficacy and safety analysis
- Stakeholder Communication: Strategically developed high-impact communications with internal and external stakeholders that provided medical safety guidance across various diseases and products, and enhanced patient education and engagement
- Key Opinion Leader Collaboration: Forged strong partnerships with KOLs in HIV and Lassa Fever, leveraged their insights to enhance clinical trial design and outcomes
- Cross-functional Team Leadership: Facilitated collaborative efforts with Clinical Trial Managers, Medical Monitors, and Data Management teams to align trial objectives and drive success in complex clinical trials
- Data Integrity and Safety Oversight: Played a pivotal role in minimizing protocol deviations and meticulously contributed critical data to the Data Monitoring Committee, ensuring the highest standards of trial integrity
- Leadership in CRA Supervision and Training: Provided exemplary supervision to CRAs in advanced data collection software, clinical data review, and use and eTMF submissions
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
Clinical Research Associate
Medpace
10.2020 - 10.2021
- Clinical Data Management and Oversight: Managed clinical data across 20 sites in four studies in oncology, cardiovascular, ophthalmology, and infectious diseases
- Cross-Functional Team Collaboration: Established strong relationships with KOLs across various therapeutic areas, served as a scientific resource in oncology-gene therapy, ophthalmology, and cardiovascular studies
- Regulatory Inspection: Coordinated inspections for drug safety-related regulatory inspections resulting in identifying multiple AEs in oncology trials through diligent monitoring and documentation
- Clinical Trial Management: Executed clinical trial activities, consulted with sites to support protocols and provide updates to Medpace CTM and Client sponsors
Clinical Research Assistant - Infectious Diseases
Wexner Medical Center, The Ohio State University
05.2018 - 10.2019
- Clinical Study Development and Management: Developed and managed a retrospective study protocol for HIV and Hepatitis C in collaboration with the clinical development team, ensuring FDA compliance including obtaining IRB approval
- Clinical Protocol and Regulatory Support: Provided scientific support for the development of clinical protocols, PK/PD analysis, safety labeling changes, and risk evaluation and minimization strategies, and essential safety inputs for submissions
- Clinical Data Management: Managed clinical studies using the REDCap eCRF database, to ensure data integrity and relevance
- Treatment Interruption Analysis: Investigated and reported on significant findings treatment interruptions in HIV/HCV cohorts
Education
Doctor of Pharmacy - Pharmacy
The Ohio State University
Columbus, OH08.2020
Bachelor of Science - Pharmacology And Toxicology
University At Buffalo (SUNY)
Buffalo, NY05.2016
Skills
- Project Management
- Protocol development
- Study Training Materials
- Clinical Development Plans
- MedDRA - Medical Coding
- ARGUS and ARISG Database
- Adjudication Activities
- Clinical Study Reports (ICSRs)
- Cross Functional Team Collaboration
- Scientific Literature Review
- Integration of Biomarkers and Data Science
- Safety Data Management and Signal Detection
- Risk Management Mitigation
- Statistical Analysis and Data Interpretation
- EDC Software-iMedidata RAVE, ClinTrak, Emmes
- Interpersonal communication
- Analytical skills
Pharmacovigilance Training
Advanced International Pharmacovigilance and Argus Safety Certification Licensee, (CCRPS), 11/22, Global Audit Programs, including maintenance of Audit Plan, SOPs, charter activities, and automation of various audit planning tools., Key tools and processes (charters, risk register, and High Chart dashboards,) to manage project communications., Pharmacovigilance and regulatory documents (PADER, PBEBR, IND Annual Reports, DSUR, ETC...)., Clinical trial process (IND, BLA, NDA) including modules on the electronic common technical document (eCTD) system.
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Pharmacovigilance Scientist and Quality Manager - Oncology Cell and Gene Therapy
Gates Institute, University of Colorado
04.2023 - 02.2024
Clinical Research Associate - Vaccines
International AIDS Vaccines Initiative
10.2021 - 01.2023
Clinical Research Associate
Medpace
10.2020 - 10.2021
Clinical Research Assistant - Infectious Diseases
Wexner Medical Center, The Ohio State University
05.2018 - 10.2019
Doctor of Pharmacy - Pharmacy
The Ohio State University
Bachelor of Science - Pharmacology And Toxicology
University At Buffalo (SUNY)
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