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Bhupal varma

@bhupalvarma

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Drug Safety Associate specializing in pharmacovigilance operations, ICSR processing, and regulatory compliance.

India

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What I'm looking for

I’m looking to contribute to a GVP/ICH-aligned drug safety team where I can own ICSR processing, SAE reporting, QC review, and signal detection, while strengthening regulatory submissions and improving safety analytics through tools like Power BI.

I’m a Drug Safety Associate and pharmacovigilance professional with 5+ years of combined experience across pharmacovigilance operations, clinical research, analytical research, and academic training. I bring hands-on expertise in ICSR processing, SAE reporting, MedDRA coding, signal detection, and submissions using Oracle ARGUS, AirsG, FAERS, and EudraVigilance under ICH E2B(R3), GVP, FDA, and EMA guidance.

I’ve supported high-impact safety work for Pfizer COVID-19 vaccine and Baxter safety projects, with a strong focus on regulatory compliance, quality review, narrative writing, and post-marketing surveillance. In roles that require accuracy and ownership, I’ve maintained 100% adherence to expedited 15-day SAE reporting timelines and performed QC review to ensure completeness, consistency, and GVP compliance.

Experience

Work history, roles, and key accomplishments

Current

Assistant Professor & Nodal Officer

Current

Yalamarty Pharmacy College

May 2022 - Present (4 years 1 month)

Trained 100+ pharmacy students on pharmacovigilance workflows, including ICSR processing, signal detection, and SAE reporting. Coordinated university compliance documentation with Andhra University and conducted practical sessions on post-marketing surveillance and risk-benefit analysis.

SAE Reporting Signal Detection Narrative Writing Post Marketing Surveillance Risk Analysis Regulatory Documentation

Drug Safety Associate

Bioclinica India (Clario)

Feb 2021 - May 2022 (1 year 3 months)

Processed and QC-reviewed 25–40 ICSR reports per day for Pfizer COVID-19 vaccine and Baxter portfolios, performing MedDRA and WHO drug dictionary coding in Oracle ARGUS and AirsG. Maintained 100% adherence to expedited 15-day SAE reporting timelines and supported FAERS and EudraVigilance submissions under ICH E2B(R3), FDA, and EMA guidance.

SAE Reporting MedDRA Coding AirsG FAERS QC Reviews Narrative Writing

Research Associate I

JODAS Expoim Pvt Ltd

Nov 2018 - Jul 2020 (1 year 8 months)

Performed analytical testing and pharmacokinetic studies for oncology and antimicrobial drug products under GLP/GMP standards. Conducted method validation and equipment calibration using OpenLab systems and supported preparation of analytical and regulatory submission documentation.

Analytical Methods Validation Equipment Calibration OpenLab Systems Post Marketing Surveillance Regulatory Reporting

Healthcare Coding Intern

WNS Global Services

Nov 2017 - May 2018 (6 months)

Performed U.S. healthcare medical coding on insurance claims data using clinical terminology, diagnosis coding, and procedure classification. Built Power BI dashboards for real-time KPI monitoring and automated ETL pipelines with Power Query to reduce manual reporting effort.

Medical Coding U.S. Healthcare Claims Clinical Terminology Diagnosis Coding Procedure Classification Power BI Power Query ETL Pipelines KPI Dashboards Healthcare Data Analytics

Medical Coding Intern

WNS Global Services

Nov 2017 - May 2018 (6 months)

Performed U.S. medical coding on healthcare insurance claims data, building experience with clinical terminology, diagnosis coding, and procedure classification. Built Power BI dashboards and automated ETL pipelines using Power Query to enable real-time KPI reporting for healthcare compliance workflows.

Medical Coding Healthcare Claims Diagnosis Coding Procedure Classification Power BI Power Query ETL Medical Terminology KPI Reporting

Education

Degrees, certifications, and relevant coursework

Yalamarty Pharmacy College

Master of Pharmacy (M.Pharmacy), Pharmacy

2016 - 2018

Activities and societies: Research project: RP-HPLC method for simultaneous estimation of naproxen and esomeprazole magnesium.

Completed M.Pharmacy at Yalamarty Pharmacy College (Andhra University). Undertook an RP-HPLC research project estimating naproxen and esomeprazole magnesium in pharmaceutical dosage forms.

Yalamarty Pharmacy College

Bachelor of Pharmacy (B.Pharmacy), Pharmacy

2011 - 2015

Activities and societies: Research project: Formulation and evaluation of ondansetron oral dispersible tablets using Stevia leaf powder and clove oil.

Completed B.Pharmacy at Yalamarty Pharmacy College (Andhra University). Conducted a formulation and evaluation project for ondansetron oral dispersible tablets using Stevia leaf powder and clove oil.