Dr Mansuri92
MBBS, MD Pharmacology | Medical Reviewer
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About
MD Pharmacology specialist with comprehensive clinical expertise as Medical Reviewer in Pharmacovigilance, Safety Case Review, and Post-Marketing Drug Safety Surveillance. Proven track record in conducting end-to-end primary medical review of Individual Case Safety Reports (ICSRs), evaluating seriousness, expectedness/listedness, and causality assessment, MedDRA coding review. Hands-on experience with Oracle ARGUS safety, VEEVA Vault safety, VigiFlow safety database (WHO IPC).
GCP-certified with peer-reviewed publications and demonstrated compliance with regulatory guidelines, seeking opportunities for the role as a Medical Reviewer or Drug Safety Physician or Medical Safety Physician.
Experience
Medical Reviewer / Medical Physician Specialist I - Fortrea (Formerly Labcorp) - Mumbai, Maharashtra, India (Full-Time Remote)
(2026-05)
- ICSR Medical Review & Triage: Perform end-to-end medical review of spontaneous, consumer, and literature-derived Individual Case Safety Reports (ICSRs), ensuring full alignment with international safety reporting standards.
- Safety & Causality Assessment: Evaluate adverse events for seriousness classification, listedness/expectedness, and causality utilizing clinical pharmacology principles and reference safety information.
- Clinical Narrative Quality: Critically review and refine clinical case narratives to establish diagnostic chronology, medical coherence, and complete presentation of relevant clinical findings.
- Medical Coding Validation: Validate MedDRA hierarchy (LLT, PT, HLT, HLGT, SOC) to ensure accurate, standardized classification of adverse reaction terms.
- Follow-up & Cumulative Evaluation: Integrate incoming follow-up clinical documentation, laboratory parameters and findings into cumulative case assessments to adjust causality and seriousness profiles.
- Quality Oversight & Query Management: Address complex medical queries, formulate targeted follow-up requests for health authorities and reporters, and perform quality checks to preserve audit-readiness.
- Safety Systems: Execute medical reviews and reconcile ARISg-migrated legacy safety cases within Oracle Argus Safety.
- Regulatory & SOP Adherence: Deliver all medical review commitments in strict compliance with internal standard operating procedures, ICH-GVP guidelines, and regional regulatory frameworks.
Senior Resident – Department of Pharmacology - GMERS Medical College & Hospital, Gotri - Vadodara, Gujarat, India
(2025-05 - 2026-05)
- Pharmacovigilance & ADR Surveillance: Institutional Adverse Drug Reaction (ADR) monitoring and reporting for the tertiary teaching hospital, conducting active surveillance across clinical departments.
- Causality & Data Entry: Performed clinical causality assessments using the WHO-UMC criteria and managed safety data entry and submission through the PvPI VigiFlow portal.
- Antimicrobial Stewardship & Audits: Actively participated in hospital prescription auditing, rational drug use evaluations, and the Institutional Antimicrobial Stewardship Committee.
- Academic Role: Delivered high-yield pharmacology lectures, clinical case tutorials and practical laboratory sessions for undergraduate MBBS and allied healthcare students.
Tutor – Department of Pathology - Dr. M. K. Shah Medical College & Research Centre - Ahmedabad, Gujarat, India
(2021-04 - 2022-02)
- Laboratory Diagnostics: Performed clinical pathology assessments, including Hematology diagnostics (CBC, peripheral blood smear evaluation), Urine microscopy, and Blood group serology.
- Blood Bank & Academic: Participated in Blood bank duty, Blood donation camps and conducted pathology practical demonstrations for MBBS students.
Education
Doctor of Medicine (MD) - Pharmacology - Parul Institute of Medical Sciences and Research (PIMSR), Parul University (2022 - 2025)
Bachelor of Medicine & Bachelor of Surgery (MBBS) - Medicine & Surgery - GCS Medical College, Hospital & Research Centre (GCS), Gujarat University (2013 - 2019)
