Summary
Overview
Work History
Education
Skills
Areas Of Interest
Roles And Responsibilities
Personal Information
Disclaimer
Timeline
Generic

Narendra Sonawane

M. Pharmacy (Pharmacology)
Jalgaon

Summary

Highly organized and detail-oriented professional with experience of 5.8 years in processing ICSR cases. Skilled in efficiently managing large volumes of data and ensuring compliance with regulatory guidelines. Seeking a challenging position where my expertise and dedication to quality will contribute to the success of the organization.

Overview

6
6
years of professional experience
3
3
Languages

Work History

Safety Data Analyst

Covance Scientific Services & Solutions Pvt. Ltd/ Labcorp drug development
04.2021 - 04.2023

Junior Safety Data Analyst

Sciformix Technologies Solutions Pvt. Ltd
07.2017 - 04.2021
  • Implement consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures
  • Ensure compliance of operations with governing regulatory requirements
  • Create, maintain, and assume accountability for a culture of high customer services
  • Execute drug safety data management processes - a combination of case entry, medical coding, narrative writing, peer review, case follow-up, report preparation
  • Implemented consistent, efficient and quality processes to meet timeliness and deliverables according to requirements and standard operating procedures

Education

Post-Graduation -

AISSMS College of Pharmacy, University of Pune

Graduation - undefined

R.C.Patel College Of Pharmacy Shirpur, North Maharashtra University

H.S.C. - undefined

Nutan Maratha college, Maharashtra Board

S.S.C. - undefined

L.N.S. Highshool, Maharashtra Board

Skills

undefined

Areas Of Interest

Medical writing

Roles And Responsibilities

  • Performing duplicate search, booking the case into Client’s corporate safety database, e.g. Argus,
    attaching the Source Document form to the case, and then routing the case appropriately either for
    primary review, data entry or invalid state.
  • Retrieving the cases by generating the appropriate work list.
  • Narrative writing
  • Coding of suspect products using ICDS and concomitant products using WHO dictionaries.
  • Coding of events, medical history, and laboratory test using MedDRA dictionaries.
  • Knowledge of WHO/MedDRA dictionaries.
  • Ensuring events in all types of cases coded appropriately.
  • Keeping the work log updated and completing the requisite trackers.
  • Determine and perform appropriate case follow-up, generating and requesting follow-up letters.
  • Client interaction for requirement gathering and various issues.

Personal Information

  • Date of Birth: 04/01/1989
  • Gender: Male
  • Nationality: Indian
  • Marital Status: Married
  • Physically handicapped (left arm affected, ~20wpm typing speed)

Disclaimer

I hereby declare that the information furnished above is true and correct to the best of my knowledge.

Timeline

Safety Data Analyst

Covance Scientific Services & Solutions Pvt. Ltd/ Labcorp drug development
04.2021 - 04.2023

Junior Safety Data Analyst

Sciformix Technologies Solutions Pvt. Ltd
07.2017 - 04.2021

Post-Graduation -

AISSMS College of Pharmacy, University of Pune

Graduation - undefined

R.C.Patel College Of Pharmacy Shirpur, North Maharashtra University

H.S.C. - undefined

Nutan Maratha college, Maharashtra Board

S.S.C. - undefined

L.N.S. Highshool, Maharashtra Board
Narendra SonawaneM. Pharmacy (Pharmacology)