Summary
Overview
Work History
Education
Skills
Additional Information
Personal details
Timeline
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Kainat Kamil

Summary

Pharmacovigilance Associate proficient in using various Safety Databases. Hands-on experience and solid foundation in analyzing drug safety data, processing diverse types of cases and ensuring compliance with regulatory standards. Excellent communication and teamwork skills supporting collaboration with cross-functional teams. Proven ability to adapt and learn quickly in evolving environments.

Overview

4
4
years of professional experience

Work History

Junior Safety Data Analyst

Fortrea Scientific Pvt. Ltd. (Previously Labcorp)
12.2021 - 08.2024
  • Managed the triage and data entry of ICSRs, ensuring compliance with reporting standards.
  • Utilized MedDRA and WHO DD for coding AEs, SAEs, and products in the Safety Database.
  • Crafted clear and concise case narratives.
  • Clarified unclear information from ICSR sender.
  • Reviewed scientific literature and international databases for new drug safety information.
  • Coordinated translation activity alongside case processing.
  • Identified and designated translation cases for language evaluation.
  • Addressed team queries and rectifying translation discrepancies.
  • Managed interactions to vendors and clients for translation tasks.
  • Types of cases handled: Spontaneous and Solicited (Serious/Non-Serious) cases received from consumers as well as Health Authorities, and Literature cases.

Safety Science Analyst

Labcorp Drug Development (Contractual)
12.2020 - 12.2021
  • Served as a case processor with additional listed responsibilities for Legal cases.
  • Created of source documents through extensive extraction of elaborate medical records and legal summons.
  • Completed data entry for legal cases along with detailed narrative writing and medical summary.
  • Transitioned to a full-time role at Labcorp post-contract period.

Education

Bachelor of Pharmacy - GPA: 6.42

MET-Institute of Pharmacy
Mumbai University
01-2020

12th Class - 72.00%

RD National College
Maharashtra State Board Higher Secondary Education
01-2016

10th Class - 84.80%

St. Joseph's Convent
Maharashtra State Board Of Secondary Education
01-2013

Skills

  • Pharmacovigilance knowledge
  • Case processing
  • Drug safety expertise
  • Good clinical practice
  • ArisGlobal
  • Argus
  • LSMV
  • MS Office Suite
  • MedDRA and WHO DD
  • Flexible and adaptable
  • Time management
  • Teamwork and collaboration

Additional Information

Prescrip Health technology LLP (05/2019 - 06/2019)

  • Verified the source accuracy and performed data entry of various drugs into the database.
  • Performed extensive Competitive Market Research and delivered presentations detailing how data can be utilized for making effective product decisions in the future.

Personal details

1. Date of birth : May 27, 1997

2. Nationality : Indian

3. Gender : Female

4. Languages : English, Hindi & Marathi

5. Hobbies : Yoga, Playing badminton, reading


Timeline

Junior Safety Data Analyst

Fortrea Scientific Pvt. Ltd. (Previously Labcorp)
12.2021 - 08.2024

Safety Science Analyst

Labcorp Drug Development (Contractual)
12.2020 - 12.2021

Bachelor of Pharmacy - GPA: 6.42

MET-Institute of Pharmacy

12th Class - 72.00%

RD National College

10th Class - 84.80%

St. Joseph's Convent
Kainat Kamil