Drug Safety and Pharmacovigilance

This program is designed for professionals aspiring to make a career in Drug Safety using the Oracle® Argus safety database.

Overview

Why Drug Safety and Pharmacovigilance

With more countries laying strict pharmacovigilance laws for drug safety, the demand for skilled professionals who can carry out surveillance trials and make reliable reports by leveraging the technological advancements in the field is more than ever.

In This Course

Learn the different stages of clinical development including Investigational New Drug Application, New Drug Application, and product labeling. Also learn how to Incorporate study design methods for consideration in the design of clinical protocols to assess safety, tolerability, and efficacy in multiple therapeutic areas.

The Sollers Advantage

Our course provides practical experience of using the Oracle Argus software and other techniques imperative for a career in Pharmacovigilance. The 3 months certificate course is designed and taught by faculty with experience in the industry.

Learning Outcomes

  • This course is based on the FDA guideline on Good pharmacovigilance practices (GVP) and is a complete training solution to acquire pharmacovigilance knowledge. Gain expertise in Clinical Research, Drug Development, Clinical Trial Design and Clinical Development
  • Understand the FDA, EU-EMA, and ICH regulations for drug safety and pharmacovigilance
  • Develop advanced knowledge of the roles and responsibilities of various functionaries in Drug Safety departments, such as the QPPV (Qualified Person for Pharmacovigilance), Drug Safety Physician, Drug Safety Data Analyst, Drug Safety Associate, Drug Safety Data Entry Associate, Drug Safety Triage Officer, Drug Safety Auditor, Drug Safety Regulatory Associate, and others
  • Practice the processes of triage, data entry, medical review, Phase IV surveillance trials, as well as reporting through the Oracle Argus software
  • Detailed training in MedDRA coding and medical narrative writing for SAE reports
  • Proficiency in handling Oracle Argus Safety database
  • Soft Skills development

Syllabus

  • Introduction to Drugs, Safety and its Regulations
  • Drug Development Process
  • Ethics of Human Subject Protection
  • Good Clinical Practice in Clinical Trials
  • Adverse Events Reporting and Post-marketing Activities
  • Adverse Events-1 in Details
  • Adverse Events-2 Med Watch, Voluntary Reports
  • Adverse Events-3 Triage and ICSR Generation
  • Introduction to Oracle Argus Safety Application
  • Features of Argus Safety
  • Role of Argus Safety in fulfilling the pharmaceutical industry’s toughest regulatory challenges
  • How Argus Safety supports drug safety business processes

INSTRUCTORS

Our instructors are not just highly experienced in the industry, they give you the personal attention you need and guide you every step of the way.

Dr. Shabana Dange

Faculty of Drug Safety and Pharmacovigilance


Dr. Durdant Dave

Dean of Academics


Shaurya Chandel

Faculty of Drug Safety and Pharmacovigilance, Oracle Argus


Nimita Limaye

Clinical Trial Management


Dr. Sandhya Gogineni

Faculty for Drug Safety and Pharmacovigilance Program


Prachi Chandel

Faculty of Drug Safety and Pharmacovigilance


Course Duration

Duration

3 Months

 

 

Engagement

150 Hours

For information regarding fee, contact our Admissions Team.

OUR STUDENTS WORK AT

Sollers partners with industry-leading corporations and provides them with ready-on-day-one employees. We record an 82% placement rate within three months of graduation.

Financial Options

Sollers has devised viable financial options for you to ensure tuition does not get in the way of your education. Now, you can focus your attention where it needs to be – in the classroom!

Career Guidance

After the completion of program, we assist our students with interview coaching, resume building sessions, conduct mock interviews, job readiness training and make them competent to venture into the corporate world.

Student Testimonials

  • Emmanet T.
    The Clinical Trial Management course is extensive, and the professors are thorough in delivering the course materials using real life experience and insight. Career Services helped me throughout the interview process, and I landed my dream job with the very first interview after graduating from Sollers.
    Emmanet T.
  • Rudolf M.
    Thanks to the academic team at Sollers, I was able to gain quick admission with financial options to pay tuition. Career Services was very helpful with resume and interview prep. They sent me job postings with major hospitals and pharma companies which helped me land my current job as Data Manager in cancer clinical trials.
    Rudolf M.

FAQs

This is a 150 Hour program

Basic knowledge to work with Computers, quick learning aptitude to get trained in newer software application tools like Oracle Argus Safety, Get trained on company SOP, Medical terminology, Clinical SAS, willing and ready to acquaint with changing regulatory landscape in Pharmacovigilance.

The exclusive training institute to take real time, hands-on training on Pharma world’s most acclaimed and advanced Oracle Argus Safety software under the guidance of industry experts.

Federally and N J state accredited and approved curriculum at modern institute with advanced video sharing white boarding, flexible schedules with facility of remote-distance learning along with in-class sessions.

Drug safety professionals are always in short supply due to increasing regulatory compliance needs to maintain Safety of each marked product for every pharmaceutical company.

Constant expansion of the market due to new drugs entering the market.

Certificate of Completion in Drug Safety and Pharmacovigilance Program.