Summary
Overview
Work History
Education
Skills
Timeline
Generic

Soumya Sharma

Data Analyst
Bhubaneshwar

Summary

Dedicated drug safety analyst with over 5 years of experience in data entry, quality review, end to end ICSR activity as per regulatory authority. Eager to learn new things, face new challenges by utilizing fullest potential of mine.

Overview

6
6
years of professional experience

Work History

Senior Drug Safety Analyst

Cognizant
7 2021 - Current
  • Working on ARGUS 8.2.3 Data Base
  • Review of cases including literature ICSR, SAE and Post marketing Spontaneous, Business partner and Regulatory cases. Collect, process, and communicate of safety information, product quality complaints and medical device incidents
  • Provide feedback to the data entry team members for the errors noted and assist in overall quality improvement of the process
  • Prepare and maintain team performance data and other project related data Client communication and acting as point of contacts for all queries and process related tasks.
  • Work within multiple databases. Maintenance of project information or Pharmacovigilance intelligence information with timely updates to the project or intelligence databases.
  • Maintain project deliverables and documentations for audits/inspection.
  • To evaluate and reconciliation of daily and monthly quality data of team.
  • Serve as support to the Safety Reporting Group management in all aspects of departmental activities, including but not limited to quality and compliance metric review, finance tracking and oversight, project resource tracking, client engagement, training oversight and CAPA oversight as designated.
  • Reconciliations with PV call center and Pharmacovigilance ICSR team
  • Act as a buddy for colleagues and provide training as required
  • Conduct refresher training for the team based on the frequent errors
  • Ensure accurate and consistent coding of medical history, drugs and adverse event terms
  • Well-versed with Safety narrative writing, MedDRA and WHODD coding
  • Responsible for the creation, follow up and closure of the AE related queries with the client or relevant department as applicable.

Operation Specialist 1

IQVIA
10.2018 - 06.2021
  • Working on ARISG and SCEPTER Data Base
  • Handling adverse event reports categorized on basis of expeditions in adherence to defined reference guidance and regulatory reporting timeframes
  • Raising appropriate queries to the marketing company for discrepancies and confirmations.
  • Ensuring accuracy and consistency of a case against the source document and recording all relevant information in the database during assessment
  • Proficient in case processing of non-serious adverse drug reactions, pregnancy cases and other medically related project information such as adverse events of special interest from various sources including clinical study, noninterventional study, spontaneous case reports and literature case reports
  • Implement consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures
  • Responsible for performing the appropriate assessments including the assessment of seriousness, and company causality for each adverse event, adhering to SOPs/other controlled documents and regulatory requirements
  • Review and evaluate AE case information to determine required action based on and following internal policies and procedures

Formulation Development Officer

Ashish Life Science Pvt Ltd
11.2017 - 10.2018
  • Working as Formulation and development officer
  • Being a formulator preparing various formula for small scale batch and implementation of this formula and procedure
  • Working on projects for EU territory.

Education

Master of Pharmacy -

Biju Patnaik University Of Technology
Bhubaneswar
04.2001 -

B. Pharmacy -

Biju Patnaik University Of Technology
Bhubaneswar
05.2015

Science -

CHSE - Odisha
Jajpur
03.2011

Skills

MedDra Codingundefined

Timeline

Operation Specialist 1

IQVIA
10.2018 - 06.2021

Formulation Development Officer

Ashish Life Science Pvt Ltd
11.2017 - 10.2018

Master of Pharmacy -

Biju Patnaik University Of Technology
04.2001 -

Senior Drug Safety Analyst

Cognizant
7 2021 - Current

B. Pharmacy -

Biju Patnaik University Of Technology

Science -

CHSE - Odisha

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Soumya SharmaData Analyst