Job Summary
Company Name
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Education
Stream
• Environmental science
• Bio-Chemistry/Bio-Technology
• Environmental science
• Bio-Chemistry/Bio-Technology
• Microbiology
• Biology
• Nursing
• Botany
• Chemistry
• Environmental science
• Zoology
Function
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• Pharmaceutical
Summary
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Job Description
Course Contents:
1. Pharmacovigilance
2. Argus Safety Software
3. Clinical Data Management
4. Oracle Clinical Software
5. Base SAS
6. Advance SAS
7. Live Project
After completion of PG Diploma:
* This is the only place in India where you can learn all the softwares Argus Safety, Oracle Clinical and SAS Clinical in single program by which you are eligible to apply in the domains of Pharmacovigilance, Clinical Data Management, Argus Safety, Oracle Clinical & SAS Clinical in 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 eligible for Clinical data management Jobs
* You are eligible for Oracle Clinical Jobs in IT Companies
* You are eligible for SAS Jobs in IT Companies
* You are also eligible for any healthcare Jobs because of the availability of the patient data in Medwin Hospitals
Features:
* This is the only Place in India where you can have practical Hands-on experience on Argus Safety database and Oracle Clinical Database
* 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 Databases
* Direct access will be provided to Argus Safety Database & Oracle Clinical 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, 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 Womans University-USA and many more
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
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
Clinical Data Management
Introduction to Clinical Research
Introduction to Clinical Data Management
Guidelines for CDM
Roles and Responsibilities of CDM Team
Clinical Data Management Process and Life cycle
Data Management Plan
21 CFR Part 11
CRF Designing
CRF Annotation
Data Capture Methods
Data Entry
Edit Checks
Data Validation Procedures
Discrepancy Management
Data Clarification Forms (DCFs)
Database Locking and Freezing
Data Storage & Archival
Data Coding and Medical Dictionaries
SAE Reconciliation
Quality Assurance & Quality Control
Auditing
CDISC Standards
Oracle Clinical OC/RDC
INTRODUCTION:
Introduction to OC window
Subsystems in OC
STUDY PLAN:
Defining Programs and Projects
Defining Organization Units
Defining Regions
Defining Planned Studies
STUDY DESIGN:
Easy Study Design
Creating Intervals
Creating Events
Creating treatment patterns
Creating Investigator, Site Records and Assignments
Creating Patient Positions and Assignments
GLIB:
Creating Questions
Creating Question Groups
Creating and Maintaining DVG’s
Copy Groups
STUDY DEFINITION:
Creating DCM’s, DCI’s & DCI Books
Validation Procedures
Derivation Procedures
Test a Study
Test Data Entry
DATA ENTRY:
Initial Login
Key Changes
First Pass Entry
Second Pass Entry
Comparison Reconciliation
Update
Browse
Patient Enrollment
Missing DCMs
STUDY CONDUCT:
Data Validation(Batch validation)
Discrepancy Management
Data Clarification Forms (DCFs)
Data Extract and SAS Extract
Making Mass Changes
Locking and Freezing
LAB:
Labs
Lab Ranges
Lab Units
Lab test questions
Lab Assignment Criteria
RDC (Remote Data Capture):
Data entry in RDC
Discrepancy Management in RDC
Study and Site Security
Clinical Research
Introduction to Clinical Research
Pharma Research/Drug Development Process
Pre-Clinical Research
Clinical Trial Phases (I – IV)
IND/NDA/ANDA
Ethics in Clinical Research
ICH-GCP Guidelines
Regulatory Affairs
US FDA Guidelines
DCGI/Schedule Y
EMA
CRO Industry
IRB / IEC
Informed Consent Process
Roles and Responsibilities of Clinical Trial Team
Site Initiation Study
CRF & e-CRF
Standard Operating Procedures (SOPs)
Investigator Brochure (IB)
Protocol Design and Format
Investigational Product (IP)
Essential Documents for a Clinical Trial
Submission & Publication of Clinical Study Report
Audits & Inspections
SAS Clinical (Base SAS and Advance SAS)
SAS Modules:
SAS / BASE
SAS / STAT
SAS / REPORT
SAS / ODS
SAS / GRAPH
SAS / SQL
SAS / MACROS
SAS / ACCESS
SAS / CONNECT
LIVE SAS CLINICAL PROJECT
Key Skill(s)
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Full Job Description for Training cum Placement Support for Pharmacovigilance/Drug Safety - Argus Safety
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