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pharmacovigilance internshiptrianing with stipend

 

Global Institute Of Advance Pharmaceutical & Health Sciences
Global Institute Of Advance Pharmaceutical & Health Sciences

 

 

Information

Advanced Certified Pharmacovigilance Training On Oracle Argus Safety Database 7.0 With MedDRA & WHODD Medical Software With 100% Placements
Course Information
GIPHS (Global Institute OF Advanced Pharmaceutical & Health Sciences) is a leading resource consulting services organization for the Pharmaceutical, Biotechnology and Medical Device industries. We offer contract and permanent job opportunities within the Pharmaceutical, Biotechnology and Medical Device industries to both experienced professionals and entry level candidates.
The services offered fall into the broad categories of Recruitment Solutions, Temporary Staffing, Outsourcing, Consulting, Application Training in Clinical Data Management (Oracle Clinical, Oracle Inform/Central Designer), Pharmacovigilance (Oracle Argus Safety Database, Oracle AERS), CDISC SDTM & SAS to aspirants of Clinical Research Industry. We successfully help some of the top Pharmaceutical, Biotechnology and Medical Device organizations from around the world to recruit high caliber experienced & trained professionals.
GIPHS (Global Institute OF Advanced Pharmaceutical & Health Sciences) has developed a tailored training division to provide Training, Internships, & Educational programmes that are designed to develop careers for clinical research professionals in Clinical Data Management, Pharmacovigilance & SAS,CDISC SDTM,Medical Writing,Medical coding & Medical Billing Trainings.

The focus of the lectures will be mainly on the following topics:
» History and over view of Pharmacovigilance
» Introduction and responsibilities: USFDA, EMA and CDSCO
» Pharmacovigilance in India
» Clinical Development process
» Different phases of clinical Trials
» 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
» Introduction to safety databases and different types
» Importance and procedure of duplicate check
» Case booking or initiation
» Introduction to MedDRA and WHODD
» Narrative writing
» Case quality check, Medical review and its submission.
» The Qualified Person for Pharmacovigilance (QPPV) in the European Economic Area
» 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

GIPHS (Global Institute OF Advanced Pharmaceutical & Health Sciences)Advantages:
» Oracle Argus Safety Database - Latest Production Version 7.0
» 4 months internship available after training
» Own CRO live projects
» Highest Placement record across all training institutes
» Industry SOPs based training
» Trainers with minimum 5 years experience
» 24 hours access to application lab
Course Timings
10:00-11:00 Am
Trainer Information
Industry Experts from Novartis, Paraxel, TechMahindra, Infosys, HCL, MakroCare, Aurobindo Pharma, Natco Pharma, Dr Reddys will deliver the classes
Eligibility Criteria
Applicants are recommended to have one of the following life Science degrees: Bachelor's, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical companies, CROs.
Training Location (Venue)
GIPHS (Global Institute of Advanced Pharmaceutical & Health Sciences)
Academy of Clinical Research
KVR Enclave, #207,2nd Floor,Beside Satyam Theater,Near Maitrivanam,
Ameerpet, Hyderabad.
Contact Information
Dr.Anita Singh
Training Coordinator
Mob No:+91 8019163577
Email: training@giphs.com
Web: www.giphs.com

 

Course Information

Pharmacovigilance ,Clinical Research,Clinical Data Management, Medical Coding, Medical Billing.

 

Contact Information

Address: Global Institute Of Advance Pharmaceutical & Health Sciences,
KVR Enclave, 2nd Floor, Gurudwara Lane, Beside Satyam Theatre Above ICICI Bank, Ameerpet, Hyderabad
Near Mythrivanam , Hyderabad , Ameerpet
PH: 04066892929 , 8019163577
Website: www.giphs.com
Email: training@giphs.com
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