Pharmacovigilance Training in Oracle Argus Safety Database

Duration: 1 month Gratisol Labs is a leading Clinical Research organization providing full range of Clinical Research, Clinical Data Management, CDISC SDTM and Pharmacovigilance training services to Healthcare Organizations. Gratisol Labs is promoted by Industry experts and experienced professionals from Clinical Research Industry. We are providing comprehensive training in Pharmacovigilance to get the Real time practical exposure on the software applications such Oracle Argus Safety Database, Who Drug Dictionary and MedDRA Dictionaries. We have a good track record of successfully organizing corporate, class room & online trainings with dynamic team of industry experienced professionals, who have delivered their full-fledged services to Pharmaceutical and Clinical Research organizations. Syllabus for Pharmacovigilance Training: Welcome and Introduction Clinical research overview Drug discovery to Submission Clinical Research Organization / Contract Research Organization Why CRO?

Basics of clinical research and Pharmacovigilance Scope of the Pharmacovigilance Pharmacovigilance Process Pharmacovigilance regulations Different types of safety reports Questions and Discussions Exercises

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Syllabus for Argus Safety Database End user Training

Data Entry Training Case Book in Case Form from Image Work list Intake E2b Import

Work list Training New, Open Reports Bulk Print Reports Bulk Transmit Local Labeling Bulk E2b Transmit etc.

Case Processing Training General Case form Patient Product Event Analysis Activities Additional Info

Regulatory Reports Case Forward/Return

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Medical Review Coding Review E2B Validation

Reports Periodic Reports (PSUR) Aggregate Reports (Line Listing)

Data Collection & Processing Receive cases from various sources Case Initiation Data Entry, Coding, Labeling, Narrative Writing Quality Check Scientific/Medical Assessment of case

After end of the each class we will be having Questions, Discussions & Exercises to prepare for the next class. New Batch Starts Every Monday. Please send an enquiry at training@gratisol.com to register for the next online demo sessions in the respective programmes. For details please contact the undersigned. A fast track weekend course will also be conducted for employees & aspirants of Clinical Research Industry. For more information, please contact Gratisol Labs at training@gratisol.com. Thanking you and assuring of our best training services. Kunal Singh Training Coordinator Gratisol Labs Plot No: 70, 3rd Floor, Road No-10, Banjara Hills, Landmark: Near Star Hospitals Hyderabad AP 500034 Contact No: 040-65741017, 64615852, 8885198390, 9705790302
3 | Copyright 2012, Gratisol Labs. All rights reserved.

E: mail: training@gratisol.com Website: www.gratisol.com

4 | Copyright 2012, Gratisol Labs. All rights reserved.