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Karthik Velusamy
#31, RJ Nagar, Bommanahalli, Bangalore-58
Mob: 9787030555 Email: karthsmart@gmail.com
Objective:
To join an organization, where I will be provided with the environment, to apply my domain knowledge and skills to bring better outcomes
in the pharmaceutical industry.
Profile Summary:
Senior Drug Safety Associate (Pharmacovigilance)
Senior Drug Safety Associate with 3 years and 6 months of individual case safety reports (ICSR) processing experience and
subject matter expert for processing of ICSR in Argus Safety database.
 Expert in handling of SAE/AE spontaneous, solicited,
social Media, literature source case types and clinical
trial cases.
 Strong knowledge in ICH and EMA guidelines (ICSR)
 Strong knowledge in MedDRA coding.
 Experience in SCEPTRE and Argus databases.
 Part of automation projects to improve the process
and deliverables.
 Handled the testing of Argus Safety database after
upgradations in HP Proton Quality centre.
Professional Experience:
QuintilesIMS
Senior Drug Safety Associate
July 2016-Present
 End to end processing including registering, data entry, medical and drug coding, narrative writing, submission and follow
up of various types of Individual Case Safety Reports (ICSR) (Spontaneous, Clinical trial, Solicited, Social Media, and
Literature) including special case types like Regulatory Authorities and Business partner cases according to standard
operating procedures and regulatory guidelines.
 Collating convention updates, and maintaining process documents to ensure team has access to all on-going process
updates.
 Mentoring new data entry personnel.
 Actively participating in client meetings to streamline the process.
Accenture Services Pvt Ltd
Pharmacovigilance Scientist
Jun 2013-Jun2016
 Processing and evaluation of Serious Adverse Events / Post Marketing Adverse Events /Non-serious events (PSP
cases, CT PMS cases, and Spontaneous cases) within agreed timeframes and to a high standard of accuracy in Argus
database.
 Ensure accurate and consistent coding of medical history, drugs and adverse event terms. Assess adverse event
reports for seriousness, causality and expectedness.
 Responsible for effective and efficient development of the safety management plan, including development of
specific processes to assure consistency within the project.
 Effectively maintains the safety database and corresponding entry guidelines, including accurate entry of data and
assurance of quality of data through quality control process.
 Preparation of study configuration requests in Argus database.
 Providing Root cause analysis, Corrective actions and Preventive actions on behalf of the team, to the health
authorities, for late submission of the cases, deviations and corrections.

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Educational Qualifications:
Title Institution Year Completed Marks
M.Pharm
(Pharmacology)
C.L.Baid Metha College of Pharmacy, Chennai-
97 2013 71%
B.Pharm Nandha College of Pharmacy, Erode-52 2010 61%
Higher Secondary Kongu Kalvi Nilayam, Erode-02 2006 61%
SSLC Vimala Matriculation School, Erode-51 2004 65%
Technical Skills:
 Intermediate: MS office-Excel, Word and PowerPoint.
 Basic: Base SQL knowledge.
 Good Understanding Citrix environment.
 Operating systems: Windows, and Linux (Ubuntu, Mint, Fedora).
Awards:
 Awarded “Numero Uno” and “Champions Trophy Award” for best performance in Accenture.
 Awarded “Client Champion” for delivery excellence of the newly transitioned products in Accenture.
 Awarded “Applause” for learning the project specific conventions quickly in QuintilesIMS.