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RESUME
Name : Ayshwarya .L
Address : No 8, B/2,
Anandhi Flats
Bazaar road, Mylapore,
Chennai
Pin-600004
Contact No : 988-***-****
Mail ID : aep83c@r.postjobfree.com
EXPERIENCE: Three years experience as medical writer
Presently working as a Aggregate safety reporting scientist in Accenture, Chennai from November 2008 till date
Experienced in writing narratives for phase IV trials and post marketed drugs
Experience in the preparation of aggregate reports such as Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), Summary Bridging Report (SBR), Clinical Overview (CO), Line Listing Addendum Report, and Safety Summary Report (SSR).
Have experience in a usage of metrics trackers and various other production trackers.
Worked as a project lead and have lead studies on various therapeutic areas such as Neuroscience, Oncology, Cardiology, Immunology, Metabolic, and anti-infectives. Have managed the studies well by work allocation and maintaing trackers.
Worked as Case Validator in Accenture, Chennai from Aug 2007 Nov 2008
Select a new case from the CARES inbox for processing.
Prints and reviews standard form/ source documents contained in the case.
Enters case information in the appropriate fields.
Encodes verbatim terms using Medical Dictionary and Regulatory Activities (MedDRA) for patient history, product indication, death information screen, and event term information.
Enters labeling for all suspect products.
Enters Reporter causality
Write narrative depending upon the type of case (i.e.: spontaneous, literature, clinical trial).
Checking for quality.
Runs Distribution Rules.
Attaches all necessary letters and/or queries in accordance with Data Entry Conventions.
Ability to read quantities of highly structured data and transcribe data to fields according to business rules with high degree of quality.
Plan and organize work so that SLAs are realized
Ensure Quality standards are met as laid out by the client and Accenture
Ensure compliance with Business policy and contractual requirements
Demonstrates the ability to work as a part of the team
Seeking advice and escalating issues when facing tasks or problems outside the normal scope of the job
Requires minimal supervision to manage daily activities and is able to meet published deadlines for activities
Occasional overtime and weekend work may be required during peak periods
Adaptable to learn new processes, concepts and skills.
Client Interaction and Team building.
SKILLS
Proficient in the use of citrix data base.
Knowledge of Oracle ARISg and Argus Safety.
Excellent knowledge of medical terminology.
Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text.
Proficient in the use of MedDRA, and searching/evaluating cases in the database
Knowledge of use of documentum database
Completed three month course in M.S.office, good knowledge of computers and excellent oral/written communication skills.
Good Computer proficiency, with ability to work with web-based applications, and familiarity with the MS XP Professional Operating System and the MS Office suite (Word/Excel/PowerPoint)
Typing and transcription accuracy
Enterprising and enthusiastic to learn and perform in new areas
ACHEIVEMENTS:
Awarded thrice in the organization for best performance award for business operator.
EDUCATIONAL QUALIFICATION :
DEGREE : M.Sc in Bioinformatics Passed from Sri Ramachandra Medical College, in
the Year, 2007 with, 72% marks.
B.Sc Allied Health Science from Sri Ramachandra Medical College in the Year, 2005 with 75% Marks.
OTHER DETAILS
Languages Known : English, Tamil and Malayalam
Date of Birth : 01 April 1984
Husband’s name : Narayanan
Marital Status : Married
Nationality : Indian
Place: Chennai
Date: 03/10/2011
(AYSHWARYA)