
- Instructor: admin
- Lectures: 46
- Students: 41
- Duration: 10 weeks
Pharmacovigilance-Argus safety database Course
The global health challenge of maximizing drug safety yet maintaining public confidence has become increasingly complex. Pharmaceutical companies are required to employ named members of staff responsible for pharmacovigilance. Health authorities grapple with the need to provide quality care whilst containing a burgeoning drug budget. Regulatory authorities must balance the potential benefits of new drugs with varying levels of suspicion of their potential harm.
Pharmacovigilance is a French term. It is a study of effects of medicines. It is used to identify side effects of drugs, their treatment, documentation and reporting. The regulatory decisions are based on them. This study is usually carried out by pharmaceutical industry to suggest warnings and recommendations of product withdrawal.
Pharmacovigilance is basically only drug related. To understand effects of any drug, they have to be widely researched on a variety of subjects and under variety of conditions.
Information Technology (IT) has transformed the world of health care and clinical medicine. Now the work of doctors and the care of patients gets along with better quality, efficiency and lower costs. Information Technology has induced clinical safety practices and creation of worldwide pharmacovigilance systems for safety standards.
The IT transformative force has fundamentally changed clinical research, practice of medicines, and medical safety monitoring. Regulators are demanding proactive surveillance programs that include comprehensive risk management plans and signal detection/ analysis throughout a clinical products life cycle.
This will enable integration of good pharmacovigilance practice in the processes and procedures to help ensure regulatory compliance and enhance clinical trial safety and post marketing surveillance.
Oracle’s Argus Safety is a comprehensive platform designed specifically to address the life sciences industry’s complex pharmacovigilance requirements. Argus Safety’s advanced database helps ensure global regulatory compliance, enables sound safety decisions and integrates safety and risk management functions, lower the cost of pharmacovigilance.
Managers and executives can obtain visibility into reporting metrics and compliance by leveraging Argus safety’s advanced reporting functionalities, such as comprehensive dashboards and metrics. In addition, Argus safety’s flexible configuration can model virtually any business process, supporting case management and reporting compliance internally as well as across license partner networks.
This intensive modular course in Pharmacovigilance- Argus safety database addresses the increasing need for well informed professionals to work in all areas related to the assessment of drug safety and risk benefit of drug use. It is an introductory course and should meet the needs of a wide variety of individuals. The variety of backgrounds and the knowledge possessed by lecturers ensures that the course has a sound mixture of the theoretical and the practical issues surrounding drug safety
What is Pharmacovigilance?
Proactive monitoring and reporting on the quality, safety and efficiency of drugs
Assessment of the risks and benefits of marketed medicines
Monitoring the impact of any corrective actions taken
Providing information to consumers, practitioners and regulators on the effective use of drugs
Designing programs and procedures for collecting and analyzing reports from patients and clinicians
Why do you need Pharmacovigilance?
Political and social pressures have increased in seeking out potential safety issues with marketed drugs.
Litigation due to the lack of Pharmacovigilance can be devastating for all concerned
Failure to practice pharmacovigilance can lead to the suspension or withdrawal of license
Specific aims of Pharmacovigilance Program
Contribute to the regulatory assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (Including cost effective) use.
Improve patient care and safety in relation to use of medicines and all medical and paramedical interventions.
Improve public health and safety in relation to use of medicines.
Promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public.
Career in Pharmacovigilance
Students in this field can get jobs in various Pharmaceutical companies and earn attractive and handsome salary packages.
Eligible Aspirants for Pharmacoviglance Course
A post graduate or graduate in Bioscience
A post graduate or graduate in Life Sciences
A post graduate or graduate with Chemistry
A post graduate or graduate with Pharmacy or Pharmaceutical Sciences
A Post graduate or graduate in Medicine
After your course completion you will be having hands on experience on below
Installing Argus Safety Database
Installing Argus safety service
Installing and configuring EDI Gateway
Installing and configuring Interchange
Performing post installation checks
Enabling IIS HTTP compression
Installing the EOSU and dsNavigator Database
Argus Integration and Third Party Attribute
Pharmacovigilance in India
Benefits of pursuing DevOps Course in ICONITINC
Aspirants will be benefited with unique features delivered by ICONIITINC
Unique Features in ICONIT INC
1.Limited Students:
We deploy dedicated trainers for each batch. Each batch consists of limited students maximum 10 in the group. Each student in the group is taken care individually. All the doubts in the session will be clarified on immediate basis. Trainers provide support in practical’s during projects.
You will be guided with case studies which help to get hands on experience on the projects as per the industry standards.
You will be attending live sessions of the trainer, no pre recorded videos.
2.Resume Preparation:
Candidate:
Why is Resume writing important?
Expert Says:
A resume is an important tool for your job search. It showcases your knowledge, your skills, experience, expertise, and accomplishments.
How ICONIT INC works here
We have remarkable proficiency in delivering job seekers the invaluable edge of dynamic, Text resumes that make them stand out from the competition. We professionally and effortlessly prosper in articulating the drawing out the strengths employers focus on when selecting candidates. Our ground-breaking, consultative approach has resulted in a strong success rate for our clients across the globe.
Our dedication and passion for bringing out the best from each draft we handle had provided us multiple opportunities for generating winning drafts for career transition and cross-functional resumes too. We are an enthusiastic and creative customer-focused writers, an experts at details, and producing quality work.
ICONITINC helps you to build a solid reputation, advance your career and command a higher salary
3.Mock Interviews:
Mock interview reflects an actual job interview. It helps to test your on-going interview preparation. It gives an opportunity to prepare, up to level of the industry standards. It gives an idea of what to say and do during the interview. A mock interview is useful in reviewing your answers to common questions and assessing other technical Skills.
ICONIT INC arranges 3 mock interviews for your actual interview preparation. It helps to practice better and become perfect to do well in the actual interview.
4.Job Assistance:
ICONIT INC will arrange 3 interviews from the top MNC’s.Candidate is purely responsible for clearing the interview.
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Pharmacovigilance-Argus safety database
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Lecture 1.1Clinical Development process
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Lecture 1.2Different phases of Clinical Trials
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Lecture 1.3CRO and Clinical Research Team
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Lecture 1.4Case Report Forms
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Lecture 1.5Data Coding
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Lecture 1.6IB, Protocol and Informed consent form
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Lecture 1.7History and overview of Pharmacovigilance
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Lecture 1.8Regulatory Authorities
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Lecture 1.9Pharmacovigilance in India
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Lecture 1.10Spontaneous reporting
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Lecture 1.11Active pharmacovigilance
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Lecture 1.12Adverse Events and its types
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Lecture 1.13Drug Safety in clinical trials and post marketed drugs
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Lecture 1.14Different sources of Adverse Events reporting
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Lecture 1.15Different types of AE Reporting Forms
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Lecture 1.16Expedited reporting and its timelines
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Lecture 1.17Aggregate reporting
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Lecture 1.18Different departments working on Pharmacovigilance
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Lecture 1.19Four factors for the reportable case
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Lecture 1.20Causality assessment of the adverse event
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Lecture 1.21MedDRA and WHODD coding
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Lecture 1.22SAE narrative writing
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Lecture 1.23PSUR and its submission timelines
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Practical Hands-on Training on Oracle Argus Safety Database Argus Console
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Lecture 2.1PV Overview
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Lecture 2.2PV Business process
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Lecture 2.3Introduction to Oracle Argus Safety Database
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Lecture 2.4Family, Product and License creation
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Lecture 2.5Clinical Study configuration
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Lecture 2.6Sites, users and Groups creation
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Lecture 2.7Workflow Configuration
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Lecture 2.8Case priority Configuration
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Lecture 2.9Case Numbering
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Lecture 2.10Field Validation
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Lecture 2.11Code list Configuration
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Argus Safety
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Lecture 3.1Different icons used during the case processing and their purpose.
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Lecture 3.2Different tabs used in case processing
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Lecture 3.3Case Bookin and Data entry
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Lecture 3.4Case Processing
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Lecture 3.5Case Routing Based on workflow
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Lecture 3.6Case Quality check, Medical review
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Lecture 3.7Duplicate case check or verification
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Lecture 3.8Report Generation for Regulatory Submission
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Lecture 3.9Expedited Reports and Aggregate Reports
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Lecture 3.10Case Bookin in LAM and Routing to Central Safety database
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Lecture 3.11MedDRA coding and WHO DD coding
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Lecture 3.12Narrative Writing
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