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bhupal V. — Mid-Level Pharmacovigilance Drug Safety Specialist from India

bhupal V.

Mid-Level Pharmacovigilance Drug Safety Specialist

India 1-2 years
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Languages
English
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About

Bhupal V. is a seasoned Drug Safety Associate and Pharmacovigilance Professional with over five years of experience in the healthcare and pharmaceutical sectors. He has extensive expertise in pharmacovigilance operations, clinical research, and analytical research. Bhupal's proficiency in ICSR processing, SAE reporting, and MedDRA coding is complemented by his adept use of databases such as Oracle ARGUS and AirsG. He has contributed significantly to Pfizer COVID-19 vaccine and Baxter safety projects, focusing on regulatory compliance and post-marketing surveillance. His current role as an Assistant Professor at Yalamarty Pharmacy College involves training students in pharmacovigilance concepts and coordinating university regulatory compliance with Andhra University. Bhupal has also excelled in managing safety databases and performing quality reviews, ensuring adherence to ICH E2B(R3) guidelines. His technical expertise is further supported by his experience in developing dashboards for healthcare operations using Power BI. Bhupal holds a Master's degree from Yalamarty Pharmacy College and has completed advanced training in clinical research and AI tool learning.

Experience

  • Assistant Professor / University Nodal Officer

    Yalamarty Pharmacy College · 2022 — Present
    Delivered training on pharmacovigilance concepts such as ICSR processing, signal detection, SAE reporting, and adverse event management. Provided education to over 100 pharmacy students on workflows related to pharmacovigilance and compliance. Coordinated regulatory documentation and compliance activities with Andhra University. Demonstrated practical knowledge in areas like post-marketing surveillance, risk-benefit analysis, and drug safety regulations. Supervised research projects related to analytical validation and pharmaceutical safety studies.
  • Drug Safety Associate

    Bioclinica India (Clario) · 2021 — 2022
    Processed and reviewed between 25 and 40 Individual Case Safety Reports (ICSRs) daily for Pfizer COVID-19 vaccine and Baxter product lines. Engaged in MedDRA and WHO Drug Dictionary coding with Oracle ARGUS and AirsG databases. Assisted in the submissions to FAERS and EudraVigilance, ensuring compliance with ICH E2B(R3), FDA, and EMA standards. Facilitated activities like case intake, duplicate checks, follow-up processing, seriousness assessment, and narrative writing. Ensured complete adherence to expedited 15-day SAE reporting timelines with precision and conducted quality control reviews to maintain consistency and compliance with GVP.
  • Research Associate-I

    JODAS EXPOIM PVT LTD · 2018 — 2020
    Conducted analytical testing and pharmacokinetic studies on oncology and antimicrobial drug products. Supported activities related to post-marketing surveillance and signal detection under GLP/GMP standards. Maintained analytical laboratory data through OpenLab systems for regulatory and quality reporting. Executed method validation, equipment calibration, and analytical documentation. Aided in drafting analytical reports and preparing regulatory submission documentation.
  • Healthcare data & U.S. Medical Coding Intern (NEEM)

    WNS Global Services · 2017 — 2018
    Performed medical coding for U.S. healthcare insurance claims data, acquiring foundational knowledge in clinical terminology, diagnosis coding, and procedure classification. Developed Power BI dashboards to enhance healthcare operations and clinical KPI monitoring for real-time reporting. Automated ETL data pipelines with Power Query and scheduled Power BI Service refreshes to streamline reporting efforts for healthcare compliance teams. Gained exposure to U.S. healthcare insurance systems related to claims processing and medical documentation standards pertinent to global pharmaceutical regulatory environments.

Skills & Expertise

Education

  • Master of Pharmacy
    Yalamarty Pharmacy College, Andhra University · 2016 — 2018
  • Bachelor of Pharmacy
    Yalamarty Pharmacy College, Andhra University · 2011 — 2015

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