Summary
Overview
Work History
Education
Skills
LNGG
Timeline
PERSONAL DEATILS
Generic

Sudarshan Gour

Hyderabad

Summary

Results-driven scientific professional prepared for Senior Drug Safety Associate role. Extensive experience in pharmacovigilance, ensuring patient safety and regulatory adherence. Focused on collaborative team efforts and delivering reliable outcomes in dynamic settings. Proficient in risk assessment and adverse event reporting.

Overview

11
11
years of professional experience

Work History

Senior Drug Safety Associate

Tata Consultancy services (TCS)
11.2019 - 09.2024
  • Responsible for full data entry of individual literature, clinical trials case safety reports into database.
  • Review and evaluate AE case information to determine validity of a case, seriousness and expeditedness as per client and internal policies and procedures.
  • Full data entry including medical coding and safetynarrative.
  • Working in Complaint remediation, medical device reporting and quality for Management database.
  • Proven experience in Complaint’s intake, investigation process, quality check and Final closure as per FDA regulatory norms.
  • Investigation and reporting of Medical Device Reports for submission to FDA, if incident meets reportable criteria for both malfunction and serious injury.
  • Complaint history review, device history review, root cause determination, investigation summary writing, and code determination.
  • Evaluate all information from a clinical and technical perspective to ensure appropriate analysis, investigation, root cause, and quality review engineering document prior to complaint closure.
  • Finding root cause of the reported allegation to identify the device failure, provide investigation summary report and solution to customer.
  • Ensure the proper documentation is maintained as per audit requirements and company policies.
  • As a Medical coder: Responsible for coding all medical history, events, drugs/procedures/indications and laboratory tests according to the appropriate dictionary (e.g. MedDRA, company product dictionary, WHO-DD).
  • As a Narrative writer: Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.

CRM Executive

Chandra Labs
11.2015 - 10.2019
  • Customer relationship executive and also performed Quality testing (analysis) of finished pharmaceutical drug products within Laboratory.

Pharmacist

Bhuvana Medicals
08.2013 - 10.2015
  • Dispensing Medicines and also performed billing at the Pharmacy.

Education

Bachelor of Pharmacy -

Scient Institute of Pharmacy
01.2013

Intermediate - undefined

Nrupatunga junior college
01.2009

S.S.C - undefined

Nrupatunga High School
01.2007

Skills

  • Case processing of patient’s adverse events reports on Safety Databases
  • Medical Coding (MedDRA)
  • Drug coding (WHO-DD) and Clinical Data Coding
  • Medidata Rave
  • Narrative Writing
  • MS Word, MS Excel, MS PowerPoint
  • Effective Communication
  • Time and priorities management
  • Attention to detail
  • Organization
  • Critical Thinking
  • Team Spirit
  • Analytical Thinking

LNGG

English
Kannada
Hindi
Telugu

Timeline

Senior Drug Safety Associate

Tata Consultancy services (TCS)
11.2019 - 09.2024

CRM Executive

Chandra Labs
11.2015 - 10.2019

Pharmacist

Bhuvana Medicals
08.2013 - 10.2015

Intermediate - undefined

Nrupatunga junior college

S.S.C - undefined

Nrupatunga High School

Bachelor of Pharmacy -

Scient Institute of Pharmacy

PERSONAL DEATILS

  • Name: S GOUR SUDARSHAN
  • Languages Known: English, Kannada, Hindi, and Telugu
  • Date of birth: 1992-07-16
  • Gender: Male
  • Nationality: Indian
  • Permanent Address: H.No: 303, 1-7-507/7, Laxmi towers, bakaram Musheerabad, Hyderabad – 500020, Telangana, India.
  • Marital status: Unmarried

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Sudarshan Gour