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VJ

Vaishali Jain

Pharmacovigilance & Drug Safety Trainee · M.Pharm

Dubai, UAE

@v_j

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About

M.Pharm professional transitioning into pharmacovigilance and drug safety, with training in ICSR intake and triage, AE/ADR assessment, MedDRA coding, case processing, and safety data review. Also experienced in healthcare content review and scientific documentation, with exposure to Argus Safety, ARISg, E2B(R3), literature screening, and PV quality checks.

Experience

  • Pharmacovigilance, Regulatory Affairs & Clinical Research Trainee
    The Pharma Daily · Indore, India
    Jul 2026 – Present

    Structured training in Pharmacovigilance, Drug Safety, Regulatory Affairs and Clinical Research; practical understanding of ICSR intake, triage, minimum case criteria, case processing, follow-up, narrative writing and safety data review; AE/ADR assessment, seriousness, severity, expectedness and suspect/concomitant medication assessment; MedDRA coding (LLT, PT, SOC) and WHO Drug Dictionary fundamentals; exposure to Argus Safety, ARISg, E2B(R3), database reconciliation and PV quality checks; literature screening, signal detection, regulatory requirements, ICH guidelines, ICH-GCP, clinical trial documentation, CTD/eCTD concepts, Excel and Power BI; completed practical exercises/projects for entry-level PV and Drug Safety readiness.

  • Healthcare Content Reviewer & Scientific Documentation Specialist
    Tinydale
    Jun 2020 – Jun 2026

    Developed and reviewed evidence-based healthcare and pharmaceutical content using reliable scientific and medical sources; conducted literature searches and evaluated scientific information for accuracy, relevance and documentation; reviewed medical terminology, references and supporting evidence; prepared patient education and health-related resources; maintained high standards of documentation, data accuracy and quality; managed remote healthcare projects independently while handling multiple assignments and deadlines.

Education

  • Master of Pharmacy
    Rajiv Gandhi Technical University
    Awarded by Rajiv Gandhi Technical University, Bhopal, India
    Pharmaceutics
  • Bachelor of Pharmacy
    Rajiv Gandhi Technical University
    Awarded by Rajiv Gandhi Technical University, Bhopal, India

Skills

5 to 8 years 5 to 8 years A long stretch - five to eight years.
Legal Research Content Editing Medical Writing Scientific Documentation
3 to 6 months 3 to 6 months A few months of practice with it.
Research Drug Safety Meddra Coding Signal Detection Pharmacovigilance Regulatory Affairs Performance Monitoring
<3 months <3 months Just getting started - under three months. This is also what shows when a level has not been set.
Icsr Processing

Tools / apps / platforms

5 to 8 years 5 to 8 years A long stretch - five to eight years.
Canva Microsoft Teams Google Workspace software
3 to 6 months 3 to 6 months A few months of practice with it.
ARISg Microsoft Excel
<3 months <3 months Just getting started - under three months. This is also what shows when a level has not been set.
Microsoft Word Microsoft Power BI Microsoft PowerPoint

Courses & certifications

  • Pharmacovigilance, Regulatory Affairs & Clinical Research Training · PharmaDaily · 2026

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