Summary
Overview
Work History
Education
Skills
Languages
Timeline
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SIVALEELA MADHURI KAYALA

HYDERABAD

Summary

Accomplished Senior Drug Safety Physician at Parexel with extensive expertise in medical case review and adverse event coding. Proven ability to provide strategic medical guidance and enhance pharmacovigilance efforts. Strong analytical skills combined with effective communication foster collaboration and drive successful outcomes in drug safety evaluations.

Overview

7
7
years of professional experience

Work History

Senior Drug Safety Physician

Parexel
Hyderabad
09.2023 - 07.2024
  • Participated in internal meetings related to drug development programs, providing medical expertise on issues related to drug safety.
  • Perform a medical case review of individual case safety reports (ICSRs), including a medical assessment of the case for seriousness, listed/labeling, causality, adverse event coding, and narrative review. Review due diligence queries as needed, and raise additional medical queries for pertinent information regarding ICSR. Provide medical support for the Analysis of Similar Events (AOSE).
  • Review of due diligence queries as needed and raise additional medical queries for pertinent information regarding ICSR
  • Provide medical support for the Analysis of Similar Events (AOSE).
  • Provide medical guidance and opinions to drug safety associates, other PVPs and scientific staff in the evaluation and follow-up of individual case safety reports.

Associate Medical Manager

Labcorp
Mumbai
12.2020 - 09.2023
  • Literature review and cases creation
  • Perform a medical case review of individual case safety reports (ICSRs), including a medical assessment of the case for seriousness, listed/labeling, causality, adverse event coding, and narrative review. Review due diligence queries as needed, and raise additional medical queries for pertinent information regarding ICSR. Provide medical support for the Analysis of Similar Events (AOSE).
  • Provide medical guidance and opinions to drug safety associates, other PVPs and scientific staff in the evaluation and follow-up of individual case safety reports.
  • Participate in signal detection efforts, e.g. Communication of a single case of interest to GMS/OCMS: Review applicable aggregate reports, such as line listings of events, on a weekly basis to assess correct seriousness classification.

Tutor

Bhaskar Medical College
Hyderabad
11.2018 - 12.2020
  • Demonstrated various teaching techniques to engage students in the learning process.
  • Assisted students in developing effective study habits and strategies for success in school.
  • Conducted individual tutoring sessions with students to help them improve their academic performance.
  • Encouraged students to ask questions about topics they did not understand.

Medical Reviewer

vigimedsafe
Hyderabad
09.2017 - 08.2018
  • Perform a medical case review of individual case safety reports (ICSRs), including a medical assessment of the case for seriousness, listed/labeling, causality, adverse event coding, and narrative review. Review due diligence queries as needed, and raise additional medical queries for pertinent information regarding ICSR. Provide medical support for the Analysis of Similar Events (AOSE).
  • Review of due diligence queries as needed and raise additional medical queries for pertinent information regarding ICSR
  • Provide medical support for the Analysis of Similar Events (AOSE).
  • Provide medical guidance and opinions to drug safety associates, other PVPs and scientific staff in the evaluation and follow-up of individual case safety reports.
  • Participate in signal detection efforts, e.g. Communication of a single case of interest to GMS/OCMS: Review applicable aggregate reports, such as line listings of events, on a weekly basis to assess correct seriousness classification.

Education

M.D. - MD Pharmacology

Gandhi Medical College
Hyderabad
05-2017

Bachelor of Science - MBBS

SVMC Medical College
Tirupati
05-2009

Skills

  • Medical case review
  • Adverse event coding
  • Adverse event assessment
  • Medical review proficiency
  • Therapeutic area expertise
  • Pharmacovigilance expertise
  • Post-marketing surveillance
  • Causality assessment
  • Literature review

Languages

Telugu
Proficient (C2)
C2
English
Proficient (C2)
C2
Hindi
Advanced (C1)
C1
Kannada
Elementary (A2)
A2

Timeline

Senior Drug Safety Physician

Parexel
09.2023 - 07.2024

Associate Medical Manager

Labcorp
12.2020 - 09.2023

Tutor

Bhaskar Medical College
11.2018 - 12.2020

Medical Reviewer

vigimedsafe
09.2017 - 08.2018

M.D. - MD Pharmacology

Gandhi Medical College

Bachelor of Science - MBBS

SVMC Medical College

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SIVALEELA MADHURI KAYALA