Industry Program In Clinical Research & Pharmacovigilance

ADVANCED CERTIFIED PROGRAM IN PHARMACOVIGILANCE

Pharmacovigilance is pharmacological science relating to detection, assessment and prevention of adverse effects of drugs. Improving drug safety is a task concerning not only regulatory authorities and pharmaceutical industry but also prescribing physicians. This is done right from the drug research and development stage to post marketing drug surveillance. 

This course will provide extensive theoretical & training in Pharmacovigilance. All the topics will be presented by team  of Doctors.  It incorporates end-to-end theoretical & practical training on Pharmacovigilance processes including case assessment practical’s (seriousness of the events, reportablity of case, expectedness of the event) , Data Entry, Case Processing, Medical coding & Narrative Writing.

Following Course Content will be covered during the training:

• Welcome and Introduction, History & Overview of Pharmacovigilance
• Drug Development and Clinical Trial Phases
• Pharmacovigilance Roles & Responsibilities in a CROs & Sponsor.
• Pharmacovigilance Process & Life cycle
• 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 database and different types
• 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

What you’ll learn

Requirements

• Any Life science, Pharmacy, Dental & Medical Graduates and Post graduates 

How are we different from Others

We are proud to present you this one-of-a-kind opportunity. There are several online courses teaching some of the skills related to the Pharmacovigilance  profession. The truth of the matter is that none of them completely prepare you. Let me explain how different is Gratisol Labs.

Pharmacovigilance is pharmacological science relating to detection, assessment and prevention of adverse effects of drugs. Improving drug safety is a task concerning not only regulatory authorities and pharmaceutical industry but also prescribing physicians. This is done right from the drug research and development stage to post marketing drug surveillance. 

Our program is different than the rest of the materials available online.

It is truly comprehensive. The Pharmacovigilance Course comprises of several modules:

• Introduction to Clinical Research
• Pharmacovigilance 
• Roles & Responsibilities of Drug Safety Associate
• Signal Detection
• Aggregate Reporting
• Hands on experience in Oracle Argus Safety Database with Live project internship experience.

These are the precise technical skills recruiters are looking for when hiring Drug Safety Associate in Pharmacovigilance department. And today, you have the chance of acquiring an invaluable advantage to get ahead of other candidates. This course will be the secret to your success. And your success is our success, so let’s make it happen!

Here are some more details of what you get with The Pharmacovigilance Course:

• Introduction to Clinical Research – Make sense of terms like Clinical Research, Clinical Research Coordinatory, Case Processing, Narrative Writing, Medical Writing, unsupervised learning, reinforcement learning, and many more;
• Pharmacovigilance – Understand Pharmacovigilance Spontaneous Adverse Event Cases and build a solid foundation. Modern software packages and programming languages are automating most of these activities, but this part of the course gives you something more valuable – critical thinking abilities;
• Database – Before you start using Pharmacovigilance, it is highly beneficial to learn about the Clinical Research theory & Practicals and acquire an understanding of why Pharmacovigilance databases are used and how they can help us manage data;
• Oracle Argus Safety Database – Case Processing, Narrative Writing, MedDRA Coding, WhoDRug Coding
• Learning a Course is meaningless without putting it to use. That’s why we integrate Clinical Research, Pharmacovigilance  & Oracle Argus Safety Database and perform several real-life Pharmacovigilance Business Intelligence tasks;

Sounds amazing, right?

Our courses are unique because our team works hard to:

• Pre-script the entire content
• Work with real-life examples
• Provide easy to understand and complete explanation
• Create beautiful and engaging animations
• Prepare exercises, course notes, quizzes, and other materials that will enhance your course taking experience
• Be there for you and provide support whenever necessary

We love teaching and we are really excited about this journey. It will get your foot in the door of an exciting and rising profession. Don’t hesitate and subscribe today. The only regret you will have is that you didn’t find this course sooner!

Who this course is for:

• Beginners to programming and data science
• Students eager to learn about job opportunities in the field of Pharmacovigilance
• Candidates willing to boost their resume by learning how to combine the knowledge of Clinical Research & Pharmacovigilance in a real-world working environment
• Drug Safety Physicians who want to develop business reasoning and apply their knowledge to the solution of various business tasks
• People interested in a Pharmacovigilance Analyst career