View All Categories

Category : Tuition Classes

Online Pharmacovigilance training in Hyderabad, India

Publish Date: 04-10-2016 17:30:42 | Contact name: BioMed Informatics | Location: India | Place: Hyderabad | 12 times displayed |

Description

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 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:

Ø Web based classroom

Ø One faculty/student

Ø Placement support

Ø Regular/Fast track/Weekend
batches

Ø Flexible timings

Ø Training Mode:
Skype/Teamviewer

Ø Hands-On Training on the
Database

Ø 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

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

Practical Hands-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

·
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:

·
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

·
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





































































































































































































































Contact BioMed Informatics: Online Pharmacovigilance training in Hyderabad, India

Phone: 04040209750

*

*

*


captcha

> Send me an email with links to manage my Ad