Pharmacovigilance Training in Oracle Argus Safety Database with Project

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:

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, 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 for further information.

Please note that we also provide separate hostel facility assistance for ladies as well as gents.

G.V.L.P. Subba Rao

BioMed Informatics

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