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Purvaja Deshpande

Clinical Data Management · Pharmacovigilance · Regulatory Affairs

Pune, Maharashtra, India

@purvaja_l_deshpande

0 followers

🎓 PG Diploma in Advanced AI-based Pharmacovigilance & Clinical Research at Savitribai Phule Pune University · Graduating 2026

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About

B.Pharm graduate with a PG Diploma in Advanced AI-based Pharmacovigilance & Clinical Research, seeking a role in Clinical Data Management or Pharmacovigilance. Hands-on practice with Oracle Argus Safety, Veeva Vault, and OCprod CDM database, with working knowledge of ICH-GCP, FDA, EMA, and CDSCO requirements.

Experience

  • Clinical Research Coordinator
    Medwind Clinical Research Pvt. Ltd. · Pune
    — – Present

    Built foundational understanding of adverse event reporting workflows at the site level, linking clinical operations to pharmacovigilance and data management. Reviewed Site Master Files for two medical device clinical trials for regulatory completeness and GCP compliance. Studied a Phase 3 clinical trial protocol, evaluating alignment with regulatory and ethical requirements.

  • AR Caller
    Vee Healthtek · Pune
    Sep 2024 – Jan 2025

    Maintained accurate medical/compliance documentation and ensured timely, accurate processing of healthcare claims.

Education

  • PG Diploma
    Savitribai Phule Pune University
    Advanced AI-based Pharmacovigilance & Clinical Research · Aug 2025 – 2026
  • Bachelor of Pharmacy (B.Pharm)
    Dr. D.Y. Patil College of Pharmacy, Akurdi, Pune
    Pharmacy · Jan 2021 – Jun 2024

Skills

<3 months <3 months Just getting started - under three months. This is also what shows when a level has not been set.
Python Meddra Coding Icsr Processing Query Management Signal Detection Pharmacovigilance Narrative writing Regulatory Affairs Data Reconciliation Data Quality Review Regulatory Compliance Adverse Event Reporting Clinical Data Management

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 SAS Microsoft Excel

Languages

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

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