Summary
Overview
Work History
Education
Skills
Timeline
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Saloni Kamani

Summary

Logical and detailed Pharmacovigilance Analyst with experience testing drugs and devices. Well-versed in complex case intake-triage-process. Highly accurate when recording data and guiding quality control while following Federal, ICH-GCP and GDP policies.

Overview

3
3
years of professional experience

Work History

Clinical Research Scientist shadowing

NYC Health + Hospitals
09.2022 - 03.2023


  • Collaborated with physicians and other healthcare professionals to evaluate the effectiveness of treatments and diagnostic techniques.
  • Recruited 18 patients by reviewing eligibility and participating in the Informed Consent process GLP and GCP standards
  • Designed, constructed and implemented research proposals, protocols and procedures.
  • Performed 5 weeks of clinical rotations at the CTO- Clinical Trials Office of Perlmutter Cancer Institute on safety reporting to IRB and FDA.

Pharmacovigilance Safety Analyst

Labcorp
01.2021 - 06.2022
  • Phase lV, Post Marketing Safety Surveillance and AE/SAE reporting of JnJ Covid-19 vaccine.
  • Processed 1850 expedited clinical and spontaneous, serious and non-serious safety cases (ESRs) using the Argus system and led a team of 12 members.
  • Managed sponsor Trial Master File (TMF) and conducted safety audits and inspections to identify workplace hazards and deficiencies.
  • Performed Intake-Triage-Process coding of AEs using MedDRA.
  • Collaborated with physicians and other healthcare professionals to evaluate the effectiveness of treatments and diagnostic techniques.
  • Monitored workplace activities to determine compliance with safety regulations and standards.
  • Trained and mentored new staff to achieve efficiency and maintain daily operational consistency.

Intern

Cytel Statistical Software and Services
01.2020 - 01.2021
  • Clinical Data Management- validated and analyzed patient data using SAS programming as per CDISC standards.
  • Conducted quality control checks on SAS codes, datasets, and outputs by verifying data accuracy, and performing discrepancy resolutions.

Education

Master of Science - Clinical Research

New York University
New York, NY
05.2023

Bachelor of Pharmacy -

World Peace University
05.2020

PG-Diploma - Drug Regulatory Affairs

Institute of Pharmaceutical Science And Research
09.2018

Skills

  • Study Protocols
  • Medical Terminology
  • Query Reporting
  • Research Protocol Development
  • Adverse Event Documentation
  • Writing Code
  • Cross-Departmental Collaboration
  • Medical Writing
  • SOP Adherence
  • Complex Data Entry

Timeline

Clinical Research Scientist shadowing

NYC Health + Hospitals
09.2022 - 03.2023

Pharmacovigilance Safety Analyst

Labcorp
01.2021 - 06.2022

Intern

Cytel Statistical Software and Services
01.2020 - 01.2021

Master of Science - Clinical Research

New York University

Bachelor of Pharmacy -

World Peace University

PG-Diploma - Drug Regulatory Affairs

Institute of Pharmaceutical Science And Research

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Saloni Kamani