Safety Data Entry
Resume:
Dr. KUNAL MESHRAM Phone No. : 408-***-**** Email:
*********@*****.***
OBJECTIVE: To obtain a position that will further develop my skills in Drug
Safety Field to contribute to the growth of the company at global level.
SUMMARY:
> Around 2 yrs experience in Drug Safety and 2+ yr experience in
Health Care Sector.
> Comprehensive knowledge of Clinical trials (Phase I - IV).
> Extensive experience working with clinical Safety data and databases.
> Acquired knowledge of regulatory and good clinical practices (GCP) and
international conference of harmonization (ICH).
> Experienced with WHO-drug, WHO Art and MedDRA coding.
> Knowledge of study activities, coding, review and clarification
activities.
> Ability to handle multiple projects with rapidly changing priorities
and deadlines.
> Dependable, Detail oriented, self- motivated professional with ability
to work individually as well in a team environment.
> Strong written and oral communication skills.
PROFESSIONAL EXPERIENCE:
Genentech Inc.
06/2012 - 01/2013
Clinical Safety Associate
> Hands on experience on gIRA, IRT, ARISg safety databases.
> Performs a review of ancillary documentation accompanying adverse
event reports and identifies pertinent clinical information entry into
global drug safety database.
> Performs data entry and coding in safety database for all molecules.
> Initiates requests for report follow up on post marketing adverse
events.
> Ensures departmental work flow processes and time lines are followed.
> Responsible for the collection, data entry, routing, follow-up and
timely reporting / submission of safety information related to drug
products from a variety of sources (consumer, healthcare
professionals, call centers etc) in compliance with SOPs, US
regulations and international regulations.
> Ensure completeness, accuracy and overall individual case quality for
data entered into the safety database and case documentation.
> Processed safety data according to applicable regulations, guidelines,
Standard Operating Procedures (SOPs) and project requirements.
> Complies with departmental standard procedures.
> Processed follow-up receipt into the gIRA for workflow tracking and
initiating associated tasks
like follow-up report prep, address queries, interfacing with USPV to
update the follow up receipt and close the sponsor acknowledgement in
gIRA.
> Follow ups by contacting healthcare professionals to gather additional
data and confirm the existing data, related to adverse events via
phone, email, fax and mail.
> Worked on reconciliation between gIRA issues and the cumulative
listing from IRT Receiver Unit.
> Review and quality control the data produced by other Drug Safety and
Clinical Safety Associates for all serious and non-serious adverse
event reports prior to completion through the safety database
workflow.
> Give task related training to the other Drug Safety Associates and
Clinical Safety Associates, whenever required.
> Process and assign cases in the validated database (gIRA, IRT) by
performing assigned roles (data entry, safety processing, and safety
reporting) within Global and local timeliness.
> Close the cases in safety database like gIRA, IRT after doing all the
follow-ups and updating & validation.
> Performs all other duties as assigned.
Unijules Life Sciences Ltd.
09/2009- 11/2010
Drug
Safety Associate
> Hands on experience on ARISg and ARGUS databases.
> Assisted in tracking information regarding potential adverse events
submitted by all reporters including consumers, healthcare
professionals, co-manufacturers, Call Centers, Medical Information,
Quality Assurance and other Company representatives accurately within
defined reporting timelines.
> Reviewed the quality of data produced by other Drug Safety Associates
for all serious adverse event reports prior to completion through the
safety database workflow.
> Reviewed and processed initial and follow-up information for both
serious and non serious adverse events in safety database by producing
a narrative using the appropriate narrative template and coding
adverse events, suspect products and concomitant products using MedDRA
and other company dictionaries within defined reporting timelines.
> Processed and assigned cases in the validated database (ARISg, ARGUS)
by performing assigned roles (data entry, safety processing, and
safety reporting) within Global and local timeliness.
> Reviewed the appropriate selection of adverse events from source
documents, appropriate MedDRA code and seriousness for each adverse
event and accuracy of label assessments for each adverse event.
> Completed the tasks resulting from departmental interfaces, e.g. with
data management (listing review, SAE reconciliation), medical writing
(narrative review).
> When needed worked with Data Management or client on reconciliation
of safety databases.
(01/2009-06/2009) at SDKSD College & Hospital, India.
Job Title: Lecturer - Department of Endodontics
(07/2008-12/2008) at SDKSD College Hospital, India.
Job Title: Clinical Assistant
(10/2007-06/2008) at Dr. Gade's Multispecialty Clinic, India.
Job Title: Clinical Assistant
EDUCATION AND PROFESSIONAL CERTIFICATION:
> Bachelor of Dental Surgery, India
> MBA in Bio-Management, USA.
COMPUTER SKILLS:
> Windows XP, MS Office Tools - MS Word, Excel, Access, PowerPoint,
Outlook.
Dr. KUNAL MESHRAM
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