BioMed Informatics Medwin Hospitals is a leading Clinical Research Organization offering full range of Pharmacovigilance, Clinical Research, Clinical Data Management, Oracle Clinical OC/RDC, Oracle Argus Safety, SAS Clinical, Regulatory Affairs&SAS CDISC SDTM, ADaM, TLF/TLGs trainings since the year of 2000that are helpful for Life Sciences/Pharmacy students to enter into IT Companies and Pharma, Biotech, CRO industries.

1. 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)
 Before joining in BioMedInformatics 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.
 We never make any phone calls to insist the candidates to join here by making
empty promises.
After completion of PG Diploma:
You can learnArgus Safety software by which you are eligible toapply
in the domains of Pharmacovigilance &Argus Safety in Cognizant,
Novartis, Quintiles, TCS, Parexel, MakroCare, Synowledge, HCL, Tech
Mahindra, Wipro, Accenture andmany more….
You are eligible for Pharmacovigilance Jobs
You are eligible for Argus safety Jobs inIT Companies
You are also eligible for any healthcare Jobs because of the availability
of the patient data in MedwinHospitals
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

2.  Direct access will be provided to Argus Safety Database
 We also offer Instructor-Led Online Trainings
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.
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, 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…
Interested candidates are kindly requested to fill 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
Mobile: 9989684450
BioMedInformatics (Established in the year of 2000)
Medwin Hospitals B Block First Floor,
Nampally, Hyderabad – 500 001
Phone: 040 – 40209750
Website: www.biomedlifesciences.com
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

3.  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 SafetyDatabase
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:

4.  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)
www.biomedlifesciences.com 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

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