Data Entry Project

Neelima Kosireddi

Email-id: ****************@*****.***; +1-201-***-****

Summary:

• Project status report (including monthly metrics) to project/functional management

• Assessed reportability of ICSRs, based on the project-specific Safety Reporting

Assessment sheet

• Participated in the triage process of incoming adverse event cases, as to ensure timely and

effective assessment and evaluation of cases

• Experience in coding using "MedDRA"

• Coordination with small regional teams of drug safety associates and safety data

coordinators on project level. Drug safety point of contact for study teams on project level.

PROFESSIONAL EXPERIENCE:

Drug Safety Associate

DPT laboratories

Lakewood, NJ

Jan 2013 to Present

Responsibilities:

• Document classification of Adverse Drug Event (ADE) reports according to the

following criteria: source, serious and non-serious, data entry priority, initial vs. follow-up

report.

• Perform triage of incoming cases to determine seriousness for prioritization of

daily work flow and performed search for duplicate cases.

• Review each AE/SAE report for accuracy, completeness, and consistency.

• Enter initial and follow-up information for individual AE case reports onto

the Drug Safety database in accordance with the current Data Entry and Process

Instructions and associated SOPs.

• Composition of concise, accurate and well written safety narrative for different

cases.

• Utilize safety databases to log, track, prioritize, and to respond to product

complaints and serious adverse events (SAEs).

• Perform Consistent MedDRA and WHO Drug coding of diseases, adverse events,

and medications using different search options (e.g., like, full, or wild card).

• Self QC (Quality Check/Control) of entire case to see consistency between source

documents, and verify narrative summery and medical coding, before transferring for

Medical Review (MR).

• Create and maintain project-specific working files, case report files and project

central files.

Drug Safety Associate

Gilead

Foster City, CA

June 2011 to Dec 2012

Responsibilities:

• Collected, documented, and processed adverse event (AE) reports from clinical

trials adhering to Standard Operating Procedures.

• Prepared clinical narrative summaries for 'Adverse Event'.

• Performed active follow-up via telephone contact with consumers and healthcare

professionals.

• Ensured timely coverage to Regulatory Authorities and pharmacist.

• Participated in preparing safety reports and maintained clinical databases.

• Perform Medical review of Individual cases safety reports to determine

Relatedness, Causality assessment, case finalization and Reportability.

• Wrote and corrected Narratives for FDA submissions.

EDUCATION

Master of Business Administration – Health Care Management, Goldey Beacom College,

Wilmington

Bachelor of Dental Surgery

NTR University of Health Sciences,

Andhra Pradesh, India

Skill Set

• Strong medical terminology

• ICD 9 and ICD10

• HIPAA

• HITECH

• Patient Protection and Affordable Care Act (PPACA)

• ICD-10 implementation

• Health Insurance Exchanges

• Affordable care act

• Claims adjudication process

• EDI

• Health Reforms

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