Medical Data Entry
Resume:
Balaji Sudarsan
Apt: GL
Waukegan, IL – 60085
***********@*****.***
Mobile No: 224-***-****
Telephone No: 847-***-****
Career Objective:
To learn and earn in depth knowledge in Pharmacovigilance and Risk Management. To enhance my skills in a work related environment and learn new things that will make me a better professional. Use my talents by putting them into good use for the benefit of the organization that I work for.
Professional Experience:
Accenture Services India Pvt Ltd:
Jan 2012 till date: On contract as Drug Safety Analyst at Abbott Pharmaceuticals.
• Trained in ICSR processing as per Abbotts conventions and SOP’s.
• ICSR processing of Initial and follow-up cases.
• Solicited, spontaneous case processing of both serious and non-serious cases.
• Social media cases and cases reported through Abbot’s website and patient control programmes.
• Processing medical product quality complaint reports and well as device quality complaint reports.
• Case creation and triaging of cases to ensure the accuracy of that determination with the potential to upgrade to serious for higher level medical review.
2009 till Dec 2011: Senior Drug Safety associate and Subject Matter Expert:
• ICSR processing.
• Triaging a case, data entry of the case in Clinical database.
• MedDRA coding of medical terms.
• Narrative writing
• Working as an SME, providing training to the new joiners.
• Working for client as an internal auditor, overseeing the work coming from Accenture
• Receive information of patients in the form of medical records i.e. AER (Adverse Event Reporting) form to asses the fundamental element of a report like Reporter details, Patient detail, specificity of an Adverse Event and Suspect Product
To read and analyze the narrative
• Perform initial checks, search database to prevent duplicate entries, create case
file and initialize received drug safety reports in the safety database
• Ensure scientific rigor through accurate, complete and consistent data entry of adverse event reports from source documents with emphasis on timeliness and quality onto the Software.
• Processing, review and distributing expedited adverse event reports as appropriate in accordance with quality standards.
• Coding of the Suspect product and Concomitant product using Company Drug Dictionary (CDD) and WHO drug dictionary respectively
• Use medical dictionaries (MedDRA coder) and business guidance to code relevant medical history and adverse event terms.
• Checking the validity of the Case whether the case is valid or invalid
• E2b validation to make Error Free Case before routing
• Processed the case to the respective workflow depend on the case criteria
• Ensure regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents as requested
• Review processed cases to verify accuracy, consistency, and compliance with process requirements, and review case data for special scenarios
• Determine if appropriate case follow-up has been considered. Conduct follow-up activities when needed.
• Develop and maintain expertise of all assigned products, of applicable corporate policies and local regulations, guidelines, Standard Operating Procedures and writing practices, of data entry conventions, and of search functions in the safety database.
• Provide oversight and team mentoring on case handling aspects and data extraction.
• Split and merge cases by analyzing cases for specific criteria and cross-referencing split cases.
• Review, rank, verify, process, and document: event terms; case classifications (validity, seriousness); special scenarios; product complaint information; medical device adverse events; reportability with due date; and accuracy and consistency. Based on assessment of cases, process accordingly.
2007 to 2009: Drug safety Associate
• Experience in SAE reporting and narrative writing.
• CRF safety review.
• Lab safety review.
• Post marketing safety review.
• Literature review and feasibility studies.
• Safety database case entry and safety review.
• MEDRA coding.
• ATC coding.
• CLINTRACE, Opticon, OCRDC, RAVE, INFORM and ARISg working experience.
• Study master file maintenance and project audit preparation.
• All individual case safety report to be to be entered in the database and write narratives relevant to the case using the appropriate conventions
• To avoid duplicates, a second duplicate check should be performed prior to data entry.
• Adopt appropriate methodologies to resolve discrepancies in the source document.
• All relevant adverse Events to be transcribed from the narrative of the source document and entered accurately.
• Code all the suspect drugs and concomitant medications according to the CDD (Company Drug Dictionary) and WHO drug dictionary.
• MEDRA coding of the adverse events and all disease terms
Professional Training
• Participated in boot camp on "Drug Development Process and SAE processing" conducted in Nov 2007 by ICON Clinical Research.
• Trained and certified by Solvay Pharmaceuticals on various aspects of pharmacovigilance and risk management including an overview of case distribution via E2B gateway.
Educational Background
1997 – 2002: BDS: Bachelor of Dental studies (Dr MGR Medical University, Chennai, Tamil Nadu - India). Academic transcripts validated by a certified assessor in USA as part of the Visa process (Transcript available for validation).
Hobbies and Interests
Leisure: Listening to music, socializing travelling, and singing in a choir
Sports: Soccer, badminton, table tennis, billiards, chess
Referees
Can be provided upon request
Passport Details:
Passport number: H4988098
Issues by: Republic of India
Date of issue: 15/12/2009
Date of expiry: 14/12/2019
Visa Type/Class: R H1B
Issue date: 11JAN2012
Expiration date: 30SEP2014
LCA and other documents available on request.
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