Pharmacovigilance-Drug Safety Physician/Medical Reviewer

Online Training-Pharmacovigilance Drug Safety Physician/Medical Reviewer

BioMed Informatics Medwin Hospitals

(Established in the year of 2000)

1. 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.
2. We never make any phone calls to insist the candidates to join here by making empty promises.

Online Training Features:

• Globally Excellent demand & highly paid jobs
• Excellent opportunity to enter into this filed
• Web based classroom
• One faculty/student
• Placement support
• Flexible timings 
• Regular/Fast track/Weekend batches
• Training Mode: Skype/Teamviewer
• Material will be provided
• Resume preparation tips / Interview guidance  
• Practical Hands-on training on Database
• Direct access will be provided to 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.

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…

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 Enquiry Form in the website www.biomedlifesciences.com for further information.

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

Website: www.biomedlifesciences.com

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
• IRB/IEC
• 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

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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 – 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

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