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
Understanding of ICH and FDA investigational and post marketing regulatory guidelines
Quality management system
Data Analysis
Quality Assurance / Quality Control
Fire safety & First aid
Training & Mentoring
Risk Management system
Documentation
Complaint Management
Vendor Evaluation
Process Validation
Multitasking
Work Prioritization
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