Online Training-Pharmacovigilance Drug Safety Physician/Medical Reviewer


View AD / Training Features in Detail

Online Training-Pharmacovigilance Drug Safety Physician/Medical Reviewer
BioMed Informatics Medwin Hospitals, Hyderabad, India
(Established in the year of 2000)

* Interactive one to one online sessions
* One faculty/student
* Flexible timings
* Regular/Fast track/Weekend
* Training Mode: Skype/Teamviewer
* Material will be provided
* Certificate will be provided after successful completion of the course
* Practical Hands-on training on Oracle Argus Safety Database
* Direct access will be provided to Oracle Argus Safety Database

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.

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 Enquiry Form in the website for further information.

G.V.L.P.Subba Rao
Mobile: +919989684450
BioMed Informatics (Established in the year of 2000)
Medwin Hospitals B Block First Floor,
Nampally, Hyderabad‚€“500 001, India
Phone: +914040209750

Course Curriculum:

* Roles and responsibilities of drug safety physician
* Roles and responsibilities of medical reviewer
* Clinical Development process
* Different phases of Clinical Trials
* SOPs, Protocol, Investigators Brochure
* Informed Consent process
* SAE reconciliation
* ICH-GCP Guidelines
* History and overview of Pharmacovigilance
* Introduction and responsibilities of USFDA, EMA and CDSCO
* Pharmacovigilance Scenario
* Adverse Events and its types
* Passive pharmacovigilance-Spontaneous reporting
* Active Pharmacovigilance- Cohort Event Monitoring
* Drug Safety in clinical trials and Post Marketing Surveillance
* 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 bookin 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
* Case Quality check
* Narrative Writing of different cases
* Medical review of Individual Case Safety Reports (ICSRs)
* Medical review of narratives
* Medical assessment of all Serious and Non-Serious Cases
* Review and modify the data entered in respect of a Case as necessary and in accordance with applicable SOPs
* Different icons used during the case processing and their purpose.
* Different tabs used in case processing
* Case Routing Based on workflow
* Minimum requirements for a case bookin
* Duplicate case check or verification
* Case Bookin and Data entry
* Case Processing
* Report Generation for Regulatory Submission
* Case Bookin in LAM and Routing to Central Safety database
* MedDRA and WHO DD coding
* Different Case Studies
* Expedited Reports and Aggregate Reports
* Periodic Reports: PSURs, CTPRs, IND and NDA

You will be extensively involved in Argus Safety
* Report preparation e.g. Periodic Safety Update Reports (PSURs), Clinical Trial Periodic Reports (CTPRs), PSUR Line Listings
* Quality checks of aggregate reports, Drug Safety Reports
* Review of published literature and case listings
* Performing medical review of individual case safety reports (ICSRs) performing medical review of narratives for Clinical Study Reports (CSRs)
* Conduct a full medical assessment of all serious and Non-Serious Cases Upgrade a Non-Serious Case to a Serious Case
* Review and modify the data entered in respect of a Case as necessary and in accordance with applicable SOPs and Approve Serious and Non-Serious Cases.
* Performing QC review of the cases to meet case processing timelines
* Writing a detailed medically oriented description of the events in the form of safety narrative.
* Assessment of seriousness, expectedness/listedness of Adverse Events
* 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
* Data entry of Individual Case Safety Reports (ICSRs) in to the Argus Safety database
* Processing of all incoming cases in order to meet timelines
* Perform the duplicate search in Argus safety database
* Evaluate the entered cases as per quality review checklist in terms of quality, accuracy, and completeness against the source documents provided
* 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.
* Entry of Adverse events in Local Affiliate Module (LAM) and Routing Local events to central Argus safety
* Meeting the timelines and supporting global regulatory submissions in expedited reporting of ICSRs
* Preparation of PSURs for regulatory submissions

BioMed Informatics, Medwin Hospitals, Hyderabad, India (Established in the year of 2000) offers the following courses

* Online Training ‚€“ Pharmacovigilance/Drug Safety in Oracle Argus Safety Database with Practical Hands on Training with Project

* Online Training-Pharmacovigilance Drug Safety Physician/Medical Reviewer

* Online Training-Argus Safety Configuration

* Online Training - Clinical Data Coordinator/Clinical Data Management in Oracle Clinical OC/RDC with Practical Hands on Training with Project

* Online Training-SAS Clinical (Base SAS, Advance SAS and Biostatistics) with Project

* Online Training- Clinical Data Analyst with Project

* Online Training-Advanced Post Graduate Diploma in Regulatory Affairs

* Online Training- SAS CDISC SDTM, ADaM, TLF/TLGs


recently viewed ads/training

Online Training-Pharmacovigilance Drug Safety Physician/Medical Reviewer

Online Training-Pharmacovigilance Drug Safety Physician/Medical Reviewer BioMed Informatics Medwin Hospitals, Hyderabad, India(Established in the year of 2000)Features:* Interactive one to one online ..


JAVA /J2EE Training
.NET Training
BI / Reporting Tool
Data Warehousing Training
Project Management Training
Business Analyst IT (BA) Training
QA / Testing tools
ERP Training
CRM Training
Database Training
SAS Training
SAP Training
Tibco Training
System Admin / Sys Admin Training
Microsoft Technologies Training
Adobe Flex Training
Biz Talk Server Training
Visual Basics training
PHP training
VMware Training
Embedded Systems training Training
PeopleSoft Training
Open source Training Courses
IOS Training
Web Development & Internet Training
Clinical Training
WebSphere Training
ILOG JRules Training
Microsoft Database and Development
ORACLE Database training
ORACLE Fusion Middleware training
ORACLE Database Administration training
ORACLE Datawarehouse training
Sharepoint Training
BizTalk Training
System / Network Administration Training
Hadoop Training
Big Data Training
Cloud Computing Training
ETL Training
Oracle Warehouse Builder (OWB) Training
apache hadoop training
Cassandra training
greenplum training
chukwa training
mongodb training
nosql training
Mobile Development Training
Open Source Software/Web Training
OS Environments Training
WebLogic Training
IBM Websphere MQ Training
IBM Websphere Server Training
Oracle SOA Suite Training
Big Data Hadoop Development Training
Big Data Hadoop Administration Training
Big Data Hadoop Combo (Hadoop Dev, Admin, NoSQL, Solr, Lucene) Training
Workday Training
DevOps Training
Mulesoft Training
Blockchain Training
Blockchain and Bitcoin Training
Neural Networks Fundamentals using TensorFlow Training
Neural Networks Training
Private Ethereum Blockchain Consortium in AWS using EC2 Training
Data Science Bootcamp Training
Comprehensive Blockchain-Work with MultiChain, Ethereum in AWS & Azure Training
Ethereum Developer: Build A Decentralized Blockchain App Training
TensorFlow for Image Recognition Training
Learn Solidity: Programing Language for Ethereum Smart Training
Dash Crypto Currency Training
Deep Learning With Tensorflow Training
Deep-Learning-Vision Training
Entrepreneurship Training
Demandware Training
Tableau Training
informatica Training
Catia Training
AWS Training
Selenium Training
Android Training
Python Training

Featured Trainings

 sap hybris   silk test   soa    coded ui   testcomplete   sap ess mss training   sap lso training   sap hana training   sap testing training   quality center training   webdynpro   sap pi   sap bi   sap ep   sap xi   sap fscd   sap scm   sap hcm   sap testing   sap mdm   sap e-recruitment   sap investment management   sap treasury training   sap pm training   sap hr-abap   abap hr curriculum   abap workflow   sap plm training   java logging tools training   java power tools training   jdbc training   java messaging service   java security training   servlets training   spring mvc training   j2ee training   hibernate training   ejb training   eclipse training   agile training   websphere live online training   apache tomcat training   design patterns training   jsf training   java me training   software design training   java ee frameworks training   java web services training   jboss training   spring framework training   struts training   jsp training   java training   core java training   sap fscm training   sap sd-crm training   sap pp-qm training   sap bo training   sap portals training   sap is retail training   sap wm training   sap is oil & gas training   oracle project accounting   spring and hibernate training   java with flex training   sap grc training   sap fsm training   sap bobj training   sap is utility training   peoplesoft training