Anika Sharma

Patient Safety Associate II

Talent

INMember since June 25, 2026

ICSR ManagementEnd-to-End WorkflowTriageBook-inData EntryMedDRA CodingNarrative AnalysisCase ReviewInvestigator's Brochure (IB) AnalyticsDashboard TrackingCross-functional MatchingQuality Control (QC) of CasesSource Document VerificationBAP Case ManagementICH E6 (R2/R3)FDA GuidelinesCIOMSEU PV LegislationArgus/ARISgExcel AnalyticsSmPCCore Data Sheet (CDS)ICH-GCPCIOMS I/VIIFDA 21 CFREU Good Pharmacovigilance Practices (GVP)

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ICSR ManagementEnd-to-End WorkflowTriageBook-inData Entry

About

Detail-oriented Pharmacovigilance professional with over 2.5 years of comprehensive experience in handling clinical trial drug safety operations. Expertise spans the end-to-end management of Individual Case Safety Reports (ICSRs) with specialized skills in MedDRA coding, Investigator's Brochure (IB) data reconciliation, narrative analysis, and rigorous Quality Control (QC) of cases. Proficient in managing complex cases including Business Continuity / Blinded-Active Product (BAP) cases, ensuring absolute compliance with global regulatory guidelines (ICH, US FDA, CIOMS, and EU PV legislation).

Experience

Drug Safety Associate I (Clinical Trials) - Parexel International (India) Private Limited - Mohali, Punjab, India

(2023-12)

End-to-End ICSR Management: Professionally triage, book-in, and execute rigorous data entry for clinical trial Individual Case Safety Reports (ICSRs) inside advanced safety databases.
MedDRA Coding: Accurately apply MedDRA coding terminology to adverse events in strict accordance with the 'MedDRA Term Selection: Points to Consider' guidelines.
Data Reconciliation & Analytics: Drive advanced reconciliation workflows between clinical databases, dashboard activities, and Investigator's Brochure (IB) analytics data to identify and rectify discrepancies.
Narrative Writing & Analysis: Synthesize and draft high-quality patient clinical narratives and evaluate event expectedness against core reference safety documents (SmPC, CDS, IB).
Quality Control (QC): Execute detailed case validation and QC checks against primary source documentation to achieve zero-defect data transmission.
Regulatory Compliance: Maintain acute awareness of global reporting deadlines to guarantee perfect compliance with ICH safety/efficacy guidelines, US FDA, CIOMS, and European Union (EU) PV legislation.