PV / Drug Safety Fresher | M.Pharmacy (Pharmaceutics), 2025

India | [email protected]

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About Me

I am an M.Pharmacy (Pharmaceutics) postgraduate and a Pharmacovigilance (PV) fresher with hands-on practice in ICSR case processing, narrative writing, seriousness assessment, and follow-up query drafting. I recently completed a simulated ICSR portfolio (SIM-001 to SIM-020) covering non-serious, serious, and special situation scenarios to strengthen my practical PV knowledge. I am actively seeking entry-level Drug Safety roles where I can contribute to patient safety and high-quality safety reporting.

Resume

Sowmya_Lakkireddy_M.Pharmacy_Fresher..pdf

Key PV Skills

• ICSR Case Processing
• Case Triage & Validity (4 criteria)
• AE/ADR, SAE & Seriousness Assessment
• Narrative Writing
• Follow-up Query Drafting
• Causality Assessment (WHO-UMC, Naranjo)
• MedDRA (Basic Awareness)
• Special Situations (Medication Error, Off-label Use, Overdose, Pregnancy Exposure)
• ICH E2A–E2F & GVP (Awareness)
• MS Excel, MS Word, PowerPoint

Portfolio Highlights

• Completed 20 simulated ICSR cases (non-serious, serious, and special situations)