Summary
Overview
Work History
Education
Skills
Auditsfaced
Professionalexperience
Projectshandled
Personal Information
Instrumentationhandled
Languages
Training
Disclaimer
Gardening, Cooking and Travelling
Timeline
Teacher
Karthik Raja

Karthik Raja

Training Lead (ICSR Case Processing)
Chennai

Summary

Reviewing Article to be identified as an Potential ICSR

Performing Duplicate check of the articles and reconciliation




Overview

15
15
years of professional experience

Work History

Literature Reviewer

Accenture Solutions Private
  • Maintained strong attention to detail while reviewing numerous documents daily, ensuring consistent quality and accuracy.
  • Enhanced team collaboration by regularly providing constructive feedback to fellow reviewers.
  • Supported continuous improvement initiatives by actively participating in team meetings, trainings, and workshops focused on enhancing reviewer skills and processes.


Training Lead

Accenture Services PVT
10.2019 - Current
  • Plan, organize and manage daily work to meet service level timelines and deliverables
  • Review Source documents attached to ICSRs of the assigned cases
  • Review all the fields for data capturing
  • Encode verbatim using MedDRA in the respective areas
  • Picking of additional events other than the reported events
  • Enter/Review/appropriate suspect to coded as in drug dictionary and conmeds to be coded under WHO dictionary
  • Enter Labels as per ICSR
  • Writing Narrative summary
  • Attach appropriate queries and follow ups
  • Responsible for completing the validation checks, E2B checks and Submission failure.

Safety Reviewer

Accenture Solutions Private
01.2018 - 03.2019
  • Maintained strong attention to detail while reviewing numerous documents daily, ensuring consistent quality and accuracy.
  • Supported continuous improvement initiatives by actively participating in team meetings, trainings, and workshops focused on enhancing reviewer skills and processes.
  • Enhanced team collaboration by regularly providing constructive feedback to fellow reviewers.
  • Increased review accuracy by implementing a comprehensive training program for new reviewers.
  • Maintained strict confidentiality with sensitive client information, adhering to industry standards and company policies.

Medical Safety Analyst

Accenture Solutions Private Ltd
06.2014 - 12.2017
  • Championed continuous improvement efforts within the Safety Department, driving innovation in established processes and routines.
  • Contributed to a positive work environment through proactive collaboration with colleagues on cross-functional teams.
  • Achieved a high level of employee engagement in safety initiatives by fostering open dialogue and incorporating feedback into program improvements.
  • Maintained up-to-date knowledge of relevant conventions and regulations, facilitating compliance across the organization.

Data Entry Analyst

Accenture Solutions Private Ltd
10.2012 - 06.2014
  • Completed data entry tasks with accuracy and efficiency.
  • Ensured data integrity by consistently cross-referencing sources and double-checking entered information.
  • Delivered consistent quality results under tight deadlines, ensuring timely completion of essential tasks and assignments.
  • Performed thorough audits of existing databases to identify discrepancies and rectify inaccuracies as necessary.
  • Trained new employees on proper data entry procedures, reducing learning curve and time-to-competency ratios.

Assistant Professor- S.Chavaan College of Pharmacy

01.2010 - 01.2012

Education

Bachelor in Pharmacy -

S.R.M college of pharmacy, Dr M.G.R University

Master of Pharmacy - Formulations And Research

K.M.C.H College of Pharmacy, Dr M.G.R University
06.2010

Post Graduate Diploma in Pharmacovigilance - ICSR Case Handling

Online
06.2012

LSPB- Green Belt - Currently Working On Quality Improvement Project

Grey Campus

Skills

External & Internal audits

Auditsfaced

  • Compliance Audit
  • UK Authority Audit
  • Internal Audit on CDP and Password protection
  • University Inspection (AICTE)

Professionalexperience

12 Years

Projectshandled

  • German Client - ICSR submission and Regulatory submission
  • USA Client- ICSR submission and Regulatory submission

Personal Information

  • Father's Name: Marimuthu PIllai
  • Date of Birth: 10/17/84
  • Nationality: Indian
  • Marital Status: Married

Instrumentationhandled

  • UV spectroscopy
  • IR Spectroscopy
  • Tablet Punching Machine (Single and Multi-tablet)
  • Dissolution Apparatus
  • All kinds of Tablet and Capsule QC Apparatus

Languages

English
Tamil
Telugu

Training

Indian Pharmacy Graduates Association, Ahmedabad

Disclaimer

I hereby declare that the information and facts stated above are true and complete to the best of my Knowledge and belief.

Gardening, Cooking and Travelling

Roof Top gardening

Cooking daily on my wish

Travel and explore places

Timeline

Training Lead

Accenture Services PVT
10.2019 - Current

Safety Reviewer

Accenture Solutions Private
01.2018 - 03.2019

Medical Safety Analyst

Accenture Solutions Private Ltd
06.2014 - 12.2017

Data Entry Analyst

Accenture Solutions Private Ltd
10.2012 - 06.2014

Assistant Professor- S.Chavaan College of Pharmacy

01.2010 - 01.2012

Literature Reviewer

Accenture Solutions Private

Bachelor in Pharmacy -

S.R.M college of pharmacy, Dr M.G.R University

Master of Pharmacy - Formulations And Research

K.M.C.H College of Pharmacy, Dr M.G.R University

Post Graduate Diploma in Pharmacovigilance - ICSR Case Handling

Online

LSPB- Green Belt - Currently Working On Quality Improvement Project

Grey Campus

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Karthik RajaTraining Lead (ICSR Case Processing)