Data Entry Medical

Sharath Rajarao

** ****** ** ****** ****, NJ ****7

**********@*******.***

201-***-****

Objective:

Experienced HCP, aspiring for Drug Safety Associate position in

Pharmacovigilance department to make a significant contribution to the

Safety team; utilizing experience of Medical & Health Science, expertise on

Argus Safety and the knowledge of FDA and EMEA/ICH regulatory guidelines.

Core Competencies:

Drug Safety: Triaging, case processing, MedDRA coding, WHO drug coding,

medical evaluation and narrative writing, familiarity in working on

different therapeutic areas

Databases: Argus database applications,

Medical skills: Medicine, Epidemiology, Biostatistics

Strengths:

. Self-motivated, goal and detail oriented, having excellent written,

presentation & communication skills

. A team player, quick learner who can formulate independent decisions.

. Strong interpersonal and organizational skills.

Education:

MS- Public Health (MPH), Rutgers University, NJ, USA

BS - Dental Surgery (BDS), RGUHS, India

Agnicient Edison, NJ

Sep 2012- April 2013

Client: Genzyme Corporation

Drug Safety Associate

. Received, documented and processed adverse event (AE) reports from

clinical trials and post-marketing in accordance with company Standard

Operating Procedures (SOPs)

. Performed initial book-in and assessment of incoming reports from

various sources such as structured and unstructured

. Performed case prioritization/Triaging based on seriousness of adverse

events in accordance with SOP guidelines

. Processed cases with an accuracy and consistency at various stages of

the system workflow

. Performed manual coding of AEs using MedDRA dictionary for the events

that were auto-encoded

. Prepared clinical narrative summaries for AE reports independently

from clinical studies and spontaneous post-marketing reports

. Performed necessary follow-up for missing, discrepant or additional

information from source documentation

. Generated queries using ARGUS interface for clarification, resolving

and forwarding to next work flow

. Performed preparation of expedited and non-expedited reports to

regulatory authorities, affiliates, as needed, to ensure compliance

with regulatory and within company time frame

. Participated in preparation of Periodic and aggregate safety reports

. Collaborated and coordinated with Data Management personnel to ensure

that key data fields are reconciled and assisted in resolving

discrepancies

. Tabulated and formatted AE's with Medwatch form for FDA regulatory

reporting and familiar working with CIOMS form for EU regulatory

reporting

Client: Genta Inc, NJ

Feb 2009 - Aug 2012

Drug Safety Associate

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

various sources such as clinical trials, post-marketing and literature

sources

. Performed detailed review of source documentation during Triaging,

data entry and case processing events in accordance with SOP's.

. Exercised clinical judgment using knowledge of FDA and ICH guidelines

and product labeling in performing initial case assessment for

seriousness, expectedness, causality and listedness

. Reviewed and manually updated system generated auto-narratives

. Performed Data entry after extracting and analyzing medical

information from records maintaining accuracy and consistency

. Performed manual coding of AEs and verified for appropriateness in

MedDRA dictionary and WHO drug conventions.

. Consistently used ARGUS features such as action items, contact log and

work list for communication and for the follow up requests

. Performed Periodic reconciliation of adverse events originating from

various trials and communicated the discrepancies with relevant

department for updating the database

. Actively worked on follow-up information requests up to the closure of

related action item

. Managed scheduling of safety reporting to health authorities along

with E2B submission compliance under EMA jurisdiction

. Assisted in the management and training of Safety Data Assistants in

assessing serious and non-serious adverse events

Affiliations:

Treasurer and Secretary of Student Graduate Association, UMDNJ-SPH, 2007-

2008

BLS (Basic Life Support) American Heart Association

Indian Dental Association

Thesis project:

Oral cancer incidence and mortality rates in twenty-one counties of New

Jersey, evaluation and implementation of core quantitative and qualitative

core concepts of Epidemiology were utilized and analyzed for the data

analysis and interpretation.

References: Available on request

Contact this candidate