Graduate Drug Safety and Pharmacovigilance

 

Unique program designed for professionals aspiring to make a career in Drug Safety using the in-demand, industry-based Oracle Argus Safety Database Software

Overview

Why Drug Safety and Pharmacovigilance

“Safety isn’t expensive; it is priceless.” This quote best explains how safety and efficacy are vital in the world of the pharmaceutical industry. Therefore, pharmacovigilance has become the prime focus in the healthcare industry to ensure that the right products reach the patients at the right time with optimized benefits and risks. Sollers College’s Drug Safety and Pharmacovigilance programs cater to the needs of this ever-growing and highly regulated industry by offering a curriculum that is in alignment with the real-time industry requirements, that is highly competent, and that equips career readiness in professionals seeking a career in the pharmaceutical industry.

In This Course

This program provides a thorough understanding of the drug development process and its life cycle, focusing in-depth on the regulatory issues across global governmental agencies like the FDA, EMA, ICH, and others that improve drug safety and efficacy. Students gain a thorough understanding of the adverse events and adverse drug reactions (ADRs), post-marketing activities and reporting guidelines, AE evaluation, seriousness, expectedness, causality, AE reporting dynamics, and MedWatch forms, and ICSR processing. Students are given access to the Oracle Argus Safety database. They are given an introduction about the Argus Safety Application, the features of Argus Safety, and the role of Argus safety in fulfilling the regulatory challenges. They are given sample cases to process during the session.

The Sollers Advantage

This program’s highlight is the hands-on access to the latest and high in-demand safety database tool used by the pharmaceutical industry, Oracle Argus 8.1.2. Our program provides practical experience of using the Argus Safety database. The 3-month certificate course is designed and taught by faculty with expertise in the industry.

Highlights

Instructors: Our instructors are physicians, pharmaceutical professionals, and Ph.D. holders, having ten years of experience in the pharmaceutical industry and currently working in a pharma company. They bridge the gap between academia and industry by guiding students and providing real-time examples and scenarios.

Argus Safety Database Software: Students are given access to the latest updated version of Oracle Argus Safety database tool – Argus 8.1.2

 Curriculum: Job-oriented, an industry-based curriculum that is aligned with the current scenario. Students will get access to the program content, batch recordings, and tools after one year of program completion. It helps in interview preparation and knowledge review.

Certification: Students will receive a course completion certificate after the completion of their internship.

Career Guidance: Students are guided by our Industry faculty with more than 30 years of experience in resume preparation and interview preparation.

References: We provide them with references for the jobs as Drug Safety Associate Intern upon successful completion of Academic Internship

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. Nimita Limaye

Faculty of Drug Safety


Dr. Shabana Dange

Faculty of Drug Safety


Dr. Jaydeep Bairagi

Faculty of Drug Safety


Santhosh Sirupa

Faculty of Drug Safety


Prof. Shaurya Chandel

Faculty of Drug Safety


Prof. Prachi Chandel

Faculty of Drug Safety


Nancy Pavan Ravuri

Faculty of Drug Safety


Prof. Renu Khurana

Faculty of Drug Safety


Kalpana Surekha Acharapu

Faculty of Drug Safety


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.

We provide exclusive one-on-one sessions with our industry-based career advisors who provide guidance right from resume feedback, assisting with interview Q&As, and helping with job preparations.

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.

Submissions of assignments, quizzes, and surveys along with financial obligation towards the college is mandatory for processing and issuing of certificate.