Advanced PG Diploma in Pharmacovigilance/Drug Safety in Oracle Argus Safety Database With Practical Hands on Training - Project Experience Certification & Placement Assistance

hyderabad,telangana, April 25, 2010 (Newswire.com) - Online/Class Room Training-Advanced PG Diploma in Pharmacovigilance/Drug Safety in Oracle Argus Safety Database with Practical Hands on Training - Project Experience Certification & Placement Assistance

BioMed Informatics Medwin Hospitals

(Established in the year of 2000)

v  Before joining in BioMed Informatics Medwin Hospitals, You are welcome to check the appointment letters of our previous students issued by MNCs like Novartis, Quintiles, Accenture, Cognizant, TCS, Parexel International (India) Pvt Ltd, MakroCare, Synowledge and so on.

v  We never make any phone calls to insist the candidates to join here by making empty promises.

After completion of PG Diploma:

   You can learn Argus Safety software by which you are eligible to apply in the domains of Pharmacovigilance & Argus Safety in Cognizant,  Novartis, Quintiles, TCS, Parexel, MakroCare, Synowledge, HCL, Tech Mahindra, Wipro, Accenture and many more….

   You are eligible for Pharmacovigilance Jobs

    You are eligible for Argus safety Jobs in IT Companies

    You are also eligiblefor any healthcare Jobs because of the availability of the patient data in Medwin Hospitals

Features:

• Certificate will be provided after successful completion of the course 
• Project experience certificate will also be provided
• Placement Support will be provided 
• Resume preparation tips / Interview guidance  
• Printed material will be provided
• Practical Hands-on training on Database
• Direct access will be provided to Argus Safety Database
• We also offer Instructor-Led Online Trainings

BioMed InformaticsMedwin Hospitalsis 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.

Our candidates employed in Novartis, Quintiles, Cognizant, TCS, Parexel International (India) Pvt Ltd,MakroCare, Synowledge, Global Hospitals, Apollo Hospitals, NIMS, Glenmark Pharmaceuticals Ltd, Jubilant, Reliance Life Sciences, ShanthaBiotechnics 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…

Interested candidates are kindly requested to fill EnquiryForm in the website 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                                                    

Mobile: 9989684450

BioMed Informatics (Established in the year of 2000)

Medwin Hospitals B Block First Floor,

Nampally, Hyderabad – 500 001

Phone: 040 – 40209750

Course Curriculum

Pharmacovigilance

• 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

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 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
• 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

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

·         Class Room Training - Advanced PG Diploma in Pharmacovigilance/Drug Safety in Oracle Argus Safety Database with Practical Hands on Training - Project Experience Certification & Placement Assistance

·         Online Training – Pharmacovigilance/Drug Safety in Oracle Argus Safety Database with Practical Hands on Training with Project

·         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​

Source: BioMed Informatics

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