Results-oriented professional with two year of pharmacovigilance experience in drug safety profiling. Proven ability and effectiveness in safety case processing of spontaneous, serious and non-serious cases. Currently working on Aris g database from Oct 2012 to till date in Synowledge as Drug safety associate.Work Experience : Drug Safety Associate Oct 2012 – present
Responsible for case intake, duplicate check, Triage, registration and maintain log of source documents and other communications.
Review and evaluate AE case information, process current incoming cases in order to meet timelines and full data entry including medical coding and safety narrative.
Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of data entered.
Other responsibilities include following up with sites regarding outstanding queries,
Follow-up on reconciliation of discrepancies,
Follow departmental AE work-flow procedures and guide the activities of a Drug Safety Associate.
Also responsible for high-level of proficiency at all work-flow tasks and perform any other drug safety related activities as assigned.Therapeutic areas covered in Pharmacovigilance : Neurology, Endocrine system and Immunology.Types of cases handled : Spontaneous cases, serious and non-serious cases.Pharmacovigilance database/systems experience : Aris-g 5.1Academic :
M. Pharmacy Krupanidhi College of Pharmacy, Bangalore. 74.57%
B. Pharmacy Bharathi College of Pharmacy, Mandya. 67%Project :Title : “PHARMACODYNAMIC INTERACTION OF SYZYGIUM CUMINI SEED KERNEL EXTRACTWITH ORAL HYPOGLYCEMICS IN DIABETIC NEUROPATHIC PAIN”.Organization : Krupanidhi College of pharmacy, Bengaluru.Description : to evaluate the role of Syzygium cumini seed kernel extract in combination with oral hypoglycemic agents (low dose) in the treatment of peripheral diabetic neuropathic pain in rats.Technical skills :
Knowledge of ICH & GCP Guidelines and Clinical Trials.
Exposure to animal handling and in vivo experiments.
Operation of Analytical Instruments like Semi Auto-analyzer, UV Spectrophotometer.
Basic computer knowledge on Microsoft-office, Internet application, Operating system : (Windows 2000, XP, 2007, Vista).Seminars Participated :
AICTE Sponsored National Seminar on “Drug Delivery – The Recent Advances” 30th July 2010. Sponsored links :
Dayanand Sagar College of Pharmacy. Bangalore.
RGUHS sponsored national seminar on “Recent Trends in Drug Discovery” 28th May, 2011. Mallige College of Pharmacy. Bangalore.
“CLE program (Continuing Library Education) - Workshop on use and access of International Chemical Abstract and International Pharmaceutical Abstract Database” June 15, 2011 at RGUHS. Bangalore.
RGUHS Sponsored Workshop on “Standardization of Herbal Drugs using Analytical Techniques” 22nd July, 2011. Bangalore.Strength :
Good communication skills.
Interested in new & innovative ideas with zeal to work in team.
Sincere and Hardworking.
Patience, confidence and dedication towards work with ambitious & self motivatedPersonal Details :DOB : 4th October 1985Father : NagarajuPermanent Address : #633, Sunanda nilaya, Sir MV Nagar, Maddur, Mandya, 571428.Languages Known : English, Hindi and Kannada.Hobbies : Sports, Music, Movies.Declaration :
I do hereby confirm that the information furnished above is true to the best of my knowledge and belief.Date :Place :
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