Pharmacovigilance Training in Oracle Argus Safety Database with Project
BioMed Informatics Medwin Hospitals
BioMed Informatics Medwin Hospitals is a leading Clinical Research Organization offering full range of Clinical Research, Clinical Data Management, Oracle Clinical OC/RDC, Pharmacovigilance, Oracle Argus Safety, SAS Clinical, IPR & Regulatory Affairs trainings since the year of 2000 that are helpful for Life Sciences/Pharmacy students to enter into IT Companies and Pharma, Biotech, CRO industries.
Oracle Argus Safety is an advanced and comprehensive adverse events (AE) management system that helps life sciences companies enable regulatory compliance, drive product stewardship, and integrate safety and risk management into one comprehensive platform. Argus Safety is industry-proven and accepted, having been used for more than a decade at leading Pharmaceutical, Biotech, CRO, and IT Companies. Trainees get hands on practical training experience to create career paths.
Mode of Training: Instructor Led Class room/Online Training
Online Training Features:
Web based classroom
One faculty/student
Placement support
Regular/Fast track/Weekend batches
Flexible timings
Training Mode: Skype/Teamviewer
Hands-On Training on the Database
Direct access to Oracle Argus Safety Database
Our candidates employed in Novartis, Quintiles, TCS, Parexel International (India) Pvt Ltd, MakroCare, Global Hospitals, Apollo Hospitals, NIMS, Glenmark Pharmaceuticals Ltd, Jubilant, Reliance Life Sciences, Shantha Biotechnics Ltd, Mahindra Satyam, SMO Clinical Research (I) Pvt Ltd, Pioneer Corporate Services Inc-USA, ICMR, AstraZeneca-UK, Texas Woman’s University-USA and many more…
Certification
Certificate will be provided for this course on successful completion of Assignments & Projects. Certificate would be awarded at the end of the program by BioMed Informatics Medwin Hospitals.
Interested candidates are kindly requested to fill the enquiry form in the website www.biomedlifesciences.com for further information.
Please note that we also provide separate hostel facility assistance for ladies as well as gents.
Contact:
G.V.L.P. Subba Rao
BioMed Informatics
Medwin Hospitals B Block First Floor,
Nampally, Hyderabad-500 001, India
Phone: 040 - 40209750
Website: www.biomedlifesciences.com
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Pharmacovigilance Training in Oracle Argus Safety Database with Project
1. Pharmacovigilance Training in Oracle Argus Safety Database with Project
BioMed Informatics Medwin Hospitals
(Established in the year of 2000)
BioMed Informatics Medwin Hospitals is a leading Clinical Research Organization offering
trainings since the year of 2000 that are helpful for Pharmacy/Life Sciences students to enter into
IT Companies and Pharma, Biotech, CRO industries.
Oracle Argus Safety is an advanced and comprehensive adverse events (AE) management
system that helps life sciences companies enable regulatory compliance, drive product
stewardship, and integrate safety and risk management into one comprehensive platform. Argus
Safety is industry-proven and accepted, having been used for more than a decade at leading
Pharmaceutical, Biotech, CRO, and IT Companies. Trainees get hands on practical training
experience to create career paths.
Online Training Features:
Web based classroom
One faculty/student
Placement support
Regular/Fast track/Weekend batches
Flexible timings
Training Mode: Skype/Teamviewer
Hands-On Training on the Database
Direct access to Oracle Argus Safety Database
Our candidates employed in Novartis, Quintiles, TCS, Parexel International (India) Pvt Ltd,
MakroCare, Synowledge, Global Hospitals, Apollo Hospitals, NIMS, Glenmark
Pharmaceuticals Ltd, Jubilant, Reliance Life Sciences, Shantha Biotechnics Ltd, Mahindra
Satyam, SMO Clinical Research (I) Pvt Ltd, Pioneer Corporate Services Inc-USA, ICMR,
AstraZeneca-UK, Texas Woman’s University-USA and many more…
Certification
Certificate will be provided for this course on successful completion of Assignments &
Projects. Certificate would be awarded at the end of the program by BioMed Informatics
Medwin Hospitals.
Interested candidates are kindly requested to fill the enquiry form in the website
www.biomedlifesciences.com for further information.
Please note that we also provide separate hostel facility assistance for ladies as well as gents.
Contact:
G.V.L.P. Subba Rao
2. BioMed Informatics (Established in the year of 2000)
Medwin Hospitals B Block First Floor,
Nampally, Hyderabad-500 001, India
Phone: 040 - 40209750
Website: www.biomedlifesciences.com
Course Curriculum:
Clinical Development process
Different phases of Clinical Trials
History and overview of Pharmacovigilance
Introduction and responsibilities of USFDA, EMA and CDSCO
Pharmacovigilance in India
Adverse Events and its types
Drug Safety in clinical trials and post marketed drugs
Different sources of Adverse Events reporting
Different types of AE Reporting Forms
Expedited reporting and its timelines
Different departments working on Pharmacovigilance
Roles and responsibilities of case receipt unit
Roles and responsibilities of Triage unit
Four factors for the reportable case
Seriousness criteria of adverse event
Expectedness or Listedness of adverse event
Causality assessment of the adverse event
Importance and procedure of duplicate check
Data Entry
Case booking or initiation
Case processing
MedDRA and WHODD coding
SAE narrative writing
Case quality check, Medical review and its submission
PSUR and its submission timelines
PracticalHands-on Training on Oracle Argus Safety Database
Argus Console:
PV Overview
PV Business process
Introduction to Oracle Argus Safety Database
Family, Product and License creation
Study creation
Sites, users and Groups creation
Workflow Configuration
Expedited Report Configuration
3. Case priority Configuration
Case Numbering
Field Validation
Code list Configuration
LAM (Local Affiliate Module) Configuration
Argus Safety:
Different icons used during the case processing and their purpose.
Different tabs used in case processing
Minimum requirements for a case bookin
Case Bookin and Data entry
Case Processing
Case Routing Based on workflow
Case Quality check, Medical review
Duplicate case check or verification
Report Generation for Regulatory Submission
Expedited Reports and Aggregate Reports
Case Bookin in LAM and Routing to Central Safety database
MedDRA coding and WHO DD coding
Narrative Writing
Different Case Studies
You will be extensively involved in Argus Safety:
Data entry of Individual Case Safety Reports (ICSRs) in to the Argus Safety database
Processing of all incoming cases in order to meet timelines
Writing a detailed medically oriented description of the events in the form of safety
narrative.
Perform the duplicate search in Argus safety database
Assessment of seriousness, expectedness/listedness of Adverse Events
Evaluate the entered cases as per quality review checklist in terms of quality, accuracy,
and completeness against the source documents provided
Performing QC review of the cases to meet case processing timelines
Coding of adverse events with the help of MedDRA and labeling the events
Coding of suspect and concomitant drugs using company and WHO-DRUG dictionaries.
Meeting the timelines and supporting global regulatory submissions in expedited
reporting of ICSRs
Preparation of PSURs for regulatory submissions
Entry of Adverse events in Local Affiliate Module (LAM) and Routing Local events to
central Argus safety
Codelist Configuration in Argus console
Creating Sites, Users, User groups
4. Creating Products, Licenses, Studies and Expedited Reporting Rules
Configuring Workflow States and rules
Knowledge of Advanced conditions; Setting up of field validation to ensure consistency
of data