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Shilpa Charly

Shilpa Charly

Medical Doctor | Pharmacovigilance & Drug Safety

Talent
MumbaiMember since September 1, 2026
Adverse Drug Reactions (ADRs)Adverse Events (AEs)ICSR ProcessingCase Validity & TriageCausality AssessmentExpectedness AssessmentClinical Assessment of CasesMedDRA TerminologyCase Narrative WritingFollow-Up AssessmentSignal Detection FundamentalsRisk-Benefit AssessmentSUSARsSAE ReportingPost-Marketing SurveillanceClinical Trial SafetySafety Database ConceptsVigiBaseFAERSEudraVigilanceICH-GCPGVPClinical ReasoningMedical Record & Case DocumentationLab/Diagnostic InterpretationMedical WritingMS ExcelPivotTablesVLOOKUPPower BI
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Adverse Drug Reactions (ADRs)Adverse Events (AEs)ICSR ProcessingCase Validity & TriageCausality Assessment

About

Medical Doctor (MD), FMGE Qualified, transitioning into Drug Safety and Pharmacovigilance. Trained in ICSR case processing, case validity and triage, seriousness, causality, and expectedness assessment, MedDRA coding, adverse event and ADR evaluation, signal detection fundamentals, and global PV regulations (ICH, GVP, FDA, EMA, MHRA, CDSCO). Strong clinical foundation with the ability to interpret patient histories, investigations, and medications, and to apply structured clinical reasoning to drug-safety case review.

Seeking an entry-level Drug Safety Physician or Medical Reviewer role.

Education

Medical Doctor in MD – Tbilisi State Medical University (2016-01 – 2022-12)

Foreign Medical Graduate Examination in FMGE – FMGE (2025-01 – 2025-12)

Skills

Medical DoctorPharmacovigilance & Drug Safety

Reviews