Medical Data Entry

Vijaya. R .Dasaraju

E-mail: *********@*****.*** Tel: 201-***-****/ 201-***-****

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OBJECTIVE:

To work efficiently and effectively as well as grow with a prestigious organization in the field of Clinical research so as to achieve realization and accomplishment of organizational goals.

QUALIFICATION SUMMARY:

3+ years experience in clinical and post marketing Adverse Event reports in the pharmaceutical industry

Assess seriousness, causality and listedness/expectedness of events, ensure accuracy, completeness and case priority of reports with appropriate company comments for timely distribution and expedited reporting

Acquired knowledge of regulatory and good clinical practices (GCP) and international conference of harmonization (ICH)

Communicate via phone/fax/email with physicians, study coordinators, consumers, care givers and other parties reporting adverse events to obtain all relevant safety information

Knowledgeable in using MedDRA to code adverse events and WHO-DD to extract information specific to the relevant drug

Medical background translates into ability to understand source documents that are complex or use confusing terminology

Team player with excellent interpersonal, analytical and problem solving skills

Ability to work well in limited timelines

Proficient with software like MSWord, MSExcel, MSPowerpoint, and safety databases (ARIS G and ARGUS)

Exceptionally proficient in writing case narratives as a result of medical knowledge

PROFESSIONAL EXPERIENCE:

Aurobindo Pharma, Dayton, NJ March 2011- Apr 2012

Drug Safety Associate

Triage of incoming spontaneous reports and assessed priority based on duplicate check for report ability and seriousness

Initial data entry of case reports into the safety database ARIS G

Performing causality judgment and coding adverse events using MedDRA

Checked the label for expectedness before coding the drug in the question with WHO-DD

Generating regulatory reports (Med watch/CIOMS)

Writing clear, concise and comprehensive case narratives including all the medically relevant information

Experienced in generating follow-up requests

Knowledgeable of FDA, ICH guidelines on good Phamacovigilance activities

Handled calls from HCPs, took accurate and correct notes to distribute to the team

Screened phone calls about Medical affairs, drug safety, AE reports etc.

Efficiently communicated with the in-house physician, nurses etc for help with medical review

Review of previously entered data and completion of data entry including writing adverse event case narrative summarizing the essential details of the case

Performed quickly and efficiently to meet company deadlines for expedited and non-expedited reports.

Entered Individual Case Safety Reports’ (ICSRs) in the company’s safety database and on the regulatory authority’s safety database.

Adhered to company SOPs for narrative writing and submission deadlines

Wrote narratives generated queries for discrepancies on SAE forms and tracked clinical trial reports. Interfaced with reporters/investigators.

Takeda Pharmaceuticals, IL Mar 2009- Feb 2011

Drug Safety Associate

Performed triage of reports of potential adverse events & checked reports for completeness and accuracy

Responsible for processing collected global AEs/SAE

Processed Spontaneous cases into safety database

Responsible for evaluation and documentation of initial, and follow-up AE documents

Responsible for writing complete medical narrative of collected AEs/SAEs

Responsible for coding of reported event term, suspect drug, and concomitant medication

Determined appropriate regulatory reporting requirements under the global regulatory guidelines (FDA regulations and ICH guidelines).

SAE cases data entry and processing.

Collect, and/or organize the data collected as part of Phamacovigilance plan.

EDUCATION:

Medical Graduate Degree [M.B.B.S]

Guntur Medical College, India.

CERTIFICATION:

Certification on “Drug Safety Associate” from- The Veritas Healthcare Solutions LLC., NY

REFERENCES: Available upon request

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