HARITULASI GULLAPUDI

• Prepared reports summarizing findings for presentations and publications.
• Assisted professors with data collection and analysis for healthcare research projects.
• Manage ongoing signal detection activities, synthesizing data from multiple sources (e.g., clinical trials, post-marketing data) for safety physician review. Author periodic signal detection reports, utilizing critical thinking and data interpretation to identify potential safety concerns.
• Compiled and distilled insights from extensive literature and database research, emphasizing critical discoveries.
• Conducted meticulous data cleansing, structured research datasets, and discerned emerging patterns.
• Support safety-related activities for clinical trials by reviewing protocols, statistical analysis plans, and the safety content in Investigator Brochures and Clinical Study Reports. Perform aggregate safety data review to ensure consistent safety monitoring.
• • Develop change management documentation, including change control forms, process maps, and training materials in accordance with 21 CFR Part 211.
• • Implement and maintain QMS policies and procedures to ensure compliance with industry standards and regulatory requirements.
• • Ensured 100% compliance with regulatory requirements, data protection laws, and ethical standards across all clinical research projects.
• • Conducted systematic literature reviews to gather relevant safety information and support safety signal evaluation and risk assessment processes.
• Experience using SAS and SQL for data analysis, including signal detection techniques like EBGM, PRR, and Bayesian Data Mining.
• Submit KPI compliance reports, identifying root causes for delays and implementing corrective actions.
• Perform statistical signal detection and data mining. Prepared reports summarizing findings for presentations and publications to detect new or emerging safety signals for drugs in development or post-market.
• Architected SQL queries tailored for health informatics ventures, optimizing data storage and retrieval.
• Assess safety trends through aggregate data analysis, identifying product quality complaints, drug safety signals, and new safety concerns emerging from real-world evidence (RWE).
• Supported students in learning healthcare data tools like Excel and Tableau.
• Collaborated with a local healthcare organization to analyze community health trends.
• Cleaned and organized datasets using Excel and SQL.
• Presented insights to stakeholders to inform health policy decisions.
• Help with overseeing direct reconciliation processes with LOCs and alliance partners.
• Analyzed patient demographics and clinical outcomes using Python and Excel

• Supervise reconciliation of safety reports, manage pharmacovigilance vendor intake and enter medical inquiry data accurately into Aris G, Argus Data bases for medical devices and oncology drugs.

• Successfully identified and escalated potential safety signals by conducting critical evaluations of adverse event reports, contributing to improved patient safety and risk management processes.

• Created and delivered comprehensive training programs on pharmacovigilance processes and regulatory compliance, enhancing team knowledge and improving overall safety monitoring practices.

• Ensure timely submission of Individual Case Safety Reports (ICSRs) to regulatory authorities using standardized formats (e.g., CIOMS, E2E, XEVMPD).

• As a Drug Safety Associate, Performed Assessment of adverse events (evaluation of listedness, seriousness standards, labeling, and case priority) in accordance with regulatory requirements

• Processed cases of suspected unexpected significant adverse reaction (SUSAR) in clinical investigations, rigorously adhering to the 7-Day and 15-Day timelines

• Responsible for daily case processing of adverse event cases (clinical trial and/or post marketed), including coding using MedDRA, determining seriousness and expectedness at the event and case level.

• Perform case follow up activities such as identification of information to be collected during follow-up.

• Utilized the company's and WHO-DRUG dictionaries to code questionable and concurrent medicines; coded verbatim terms using Med DRA for patient history, investigations, product indication and event terms

• Ensured that data was gathered in accordance with departmental SOPs and updated and uploaded the proper data into the clinical database

• Peer reviews of cases for quality, consistency, and accuracy as needed

• Used the ArisG and Argus database, adverse event and major adverse event data was gathered, processed, and reported to the appropriate authorities for use in connection with marketed and investigational medications.

• Researched relevant scientific literature when necessary, in order to provide accurate input into drug safety assessments.

• Participated in meetings with internal stakeholders, external partners, and health authorities regarding drug safety matters.

• Conducted literature reviews to assess emerging safety information on drugs in development or marketed products.

• Gather adverse events (AE) and adverse drug reaction (ADR) reports from various sources, including clinical trials, spontaneous reports, literature, health authorities, and healthcare providers.

• Develop and track key performance indicators (KPIs) related to pharmacovigilance activities to ensure compliance and performance targets are met.

• Prepare and submit PSURs or PBRERs to regulatory agencies to provide an overview of the safety profile of a drug over a specific period, ensuring the report reflects new data from all available sources

• Conduct thorough impact assessments in alignment with 21 CFR Part 314 (Applications for FDA Approval to Market a New Drug) to understand the potential effects of proposed changes on product safety and quality.

• Stay abreast of global regulations pertaining to medical information and pharmacovigilance, offering regulatory guidance to colleagues and clients.

• Identified and escalated individual Case Safety Reports and technical product complaints to appropriate stakeholders within established timelines

• Processed Case Report Forms (CRFs), perform data cleaning, classification, and generate study summaries.

• Adhered to GCP guidelines and regulatory regulations, serving as the pharmacovigilance SME for more than 25 project meetings, ensuring compliance and best practices.

• Maintained an exceptional productivity rate of 99.3%, ensuring thorough triage, case processing and adherence to timelines.

• Served as Subject Matter Expert (SME) for a team, overseeing the adverse event case processing of ICSRs, clinical trial and regulatory reports and MDR’s.

• Handled diverse responsibilities, including data entry, adverse event documentation, medDRA coding, narrative writing, and follow-up in the ArisG database.

• Scheduled and led meetings and knowledge transfer sessions to address major and minor errors, implementing RCA and CAPA, deviation management and documentation.

• Maintain and update pharmacovigilance databases (e.g., Argus, ARISg, Veeva Vault) and ensure they are properly configured to support data capture, processing, and reporting of adverse events.

• Coordinated internal and external audits, demonstrating a commitment to compliance with industry guidelines.

• Successfully managed data reconciliation, therapeutic area data management, SAE reconciliation, and local laboratory data management.

• Responsible for sterilizing and preparing operators, welcoming patients, and managing their check-in process. Monitored inventory and assisted in the delivery of dental supplies, ensuring all materials were accounted for. Scheduled and managed patient appointments, ensuring efficient clinic operations.

• Maintained accurate patient records, both manually and digitally, enhancing data integrity. Assisted in recording treatment information, ensuring thorough documentation. Prepared patients for procedures, ensuring comfort and understanding of processes. Sterilized instruments and maintained a clean clinical environment to uphold safety standards.

• Created educational materials to enhance patient understanding of dental procedures. Assisted dentists during various procedures, ensuring efficient workflow and patient comfort. Participated in community dental camps, providing care and education to underserved populations

• Welcomed patients professionally, managing appointments and insurance communications effectively.

• Performed routine dental procedures including cleaning, cavity fillings, and extractions under supervision. Conducted oral examinations and diagnosed dental conditions.

• Educated patients on oral hygiene practices and post-procedure care. Assisted senior dentists with complex procedures such as root canals, crowns, and bridges.

• Maintained accurate patient records and ensured adherence to infection control protocols. Provided basic dental care to underserved communities during dental camps.

• Supported patient intake, preliminary examinations, and treatment planning. Promoted oral health awareness through educational sessions.

• Utilized Patterson Eagle Software to assist in four-handed dentistry, including composite and surgical extractions. Set up operative trays and performed digital and panoramic x-rays, ensuring patient comfort. Learned and applied sterilization techniques, maintaining a clean and safe environment.

• Assisted in oral and maxillofacial surgeries, providing post-operative care and support. Created custom bleaching trays and observed various gum surgeries to enhance procedural knowledge.