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RS

Rushikesh Madhukar sonawane

B.Pharm graduate · Pharmacovigilance & Regulatory Affairs trainee

Pune, Maharashtra, India

@rushikesh_madhukar_sonawane

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About

B.Pharm graduate with an Advanced Post-Graduate Diploma in Pharmacovigilance, Clinical Research, Clinical Data Management & Regulatory Affairs. Trained in ICSR case processing, MedDRA coding, safety review, data validation, and regulatory documentation, with hands-on simulated experience using Oracle Argus.

Experience

  • Industry Intern – Quality Assurance & Regulatory Affairs
    Red Cross Formulation Pvt. Ltd. · Maharashtra
    Jun 2024 – Jul 2024

    Assisted in preparation, review and reconciliation of regulatory documentation and compliance records. Supported data integrity checks and audit-readiness activities for QC/QA departments. Worked under established GMP and QA procedures with attention to documentation accuracy and completeness.

Education

  • Advanced PG Diploma
    Pharmacovigilance, Clinical Research · Jan 2026 – Apr 2026
  • Bachelor of Pharmacy (B.Pharm)
    Mrs. Saraswati Wani College of Pharmacy
    Awarded by Dr. BATU, Lonere
    Pharmacy · Dec 2021 – Jun 2025

Skills

<3 months <3 months Just getting started - under three months. This is also what shows when a level has not been set.
GMP GLP GDP Gvp Data Review Meddra Coding Data Integrity Case Management Data validation Audit Readiness Query Management Regulatory Affairs Follow-up tracking Data Reconciliation Duplicate detection Causality Assessment Information Extraction

Tools / apps / platforms

<3 months <3 months Just getting started - under three months. This is also what shows when a level has not been set.
GCP ARISg Microsoft Office

Languages

Fluent Fluent Comfortable using it for work.
Hindi Speak English Speak Marathi Speak

Projects

  • Formulation & Evaluation of Polyherbal Anti-Acne Cream

    Literature-based safety evaluation and ADR risk analysis with GLP/QA documentation.

  • Simulated ICSR Case Processing & Safety Lifecycle Management
    Oracle Argus Safety

    Simulated end-to-end ICSR workflows including case intake, data entry, MedDRA coding, medical narrative writing, duplicate checks, triage, seriousness/expectedness review, causality assessment, follow-up tracking, and patient-identifiable information redaction.

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