Falguni Shelke

Falguni Shelke

B.Pharm student · Entry-level Pharmacovigilance & Drug Safety

Pune, Maharashtra, India

@falguni_shelke

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🎓 Bachelor of Pharmacy (B.Pharm) at Savitribai Phule Pune University · Graduating 2027

About

B.Pharm student graduating in 2027 with simulation-based training in pharmacovigilance and ICSR case processing. Familiar with case intake, triage, MedDRA coding, narrative writing, follow-up, signal detection, and safety assessment concepts.

Education

  • Bachelor of Pharmacy (B.Pharm)
    Sinhgad Institute of Pharmacy, Pune
    Pharmacy · Sep 2023 – Jun 2027

Skills

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.
Microsoft Word Microsoft Excel Microsoft PowerPoint

Languages

Native / Bilingual Native / Bilingual Their first language, or as strong as one.
Marathi Speak
Fluent Fluent Comfortable using it for work.
Hindi Speak
Conversational Conversational Can hold an everyday conversation.
English Speak

Projects

  • Pharmacovigilance ICSR Case Processing Simulation
    WHO-UMC, MedDRA, E2B(R3)

    Processed simulated Individual Case Safety Reports through intake, validation, triage, medical assessment, follow-up, duplicate review, quality control, and case closure. Mapped case information to E2B(R3) data elements and drafted chronological safety narratives.

  • Signal Detection and Safety Assessment Simulation
    PRR, ROR, Information Component

    Conducted simulated disproportionality analysis, signal validation and prioritization, and structured benefit-risk assessment using statistical, clinical, literature, and regulatory considerations.

Courses & certifications

  • Advanced course in Pharmacovigilance · Udemy · 2026

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