Advanced 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 Advanced 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, and focuses in-depth on the regulatory issues across global governmental agencies like the FDA, EMA, ICH, and others that improve the drugs’ safety and efficacy. This program educates students about the pharmaceutical industry’s business dynamics and the ethics, structure, the function of the drug safety department, and training. 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. Based on the in-depth theoretical knowledge gained, hands-on 12-week internship training is provided using the industry-based Oracle Argus Safety database. In the internship, students develop the ability to extract relevant information from varied sources to triage the assigned cases into serious or non-serious and process the cases according to industry standards.

The Sollers Advantage

This advanced program’s highlight is the 12-week In-house Internship Program that provides hands-on access to the latest and high in-demand safety database tool used by the pharmaceutical industry, Oracle Argus 8.1.2. In our internship program, students work as drug safety associates, drug safety specialists, pharmacovigilance associates, pharmacovigilance specialists, clinical trial safety associates, and clinical safety specialists to acquire knowledge and become job-ready from day 1. They process all types of cases that include literature, valid, spontaneous, clinical trials, invalid, serious, non-serious, at risk, and lack of efficacy cases.

Why Sollers – 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 SoftwareHands-on 12+ weeks internship provided using updated industry-based software tools. For the Advanced drug safety and pharmacovigilance program, we give access to the latest updated version of the Oracle Argus Safety database tool – Argus 8.1.2.

Internship Program: In our internship programs, students work as drug safety associates, drug safety specialists, pharmacovigilance associates, pharmacovigilance specialists, clinical trial safety associates, and clinical safety specialists to acquire knowledge and become job-ready from day 1.

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 up to 1 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 Career Advisor with 15 to 30 years of experience in related domains and support the students in resume and interview preparation.

References: We provide students with Academic references for the jobs as a Drug Safety Associate Intern upon completing the Academic Internship.

Learning Outcomes

  • 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, statistical analysis, implementation of REMS (Risk Evaluation and Mitigation Strategy), Phase IV surveillance trials, Regulatory Writer for Labels, and Pharmacovigilance Strategy, as well as reporting through the Oracle® Argus software
  • Internship in Oracle Argus Software – In this 12-week internship phase, students achieve practical experience in processing ICSRs from book-in to distribution along with writing case narrative using Oracle Argus 8.1.2. They are given exposure to various real-time, live cases like serious, non-serious, at risk, lack of efficacy cases, literature, spontaneous cases, invalid cases, and clinical trial cases. They also get hands-on experience of working on coding for medical history, ADRs using WHO drug dictionary and MedDRA.
  • Detailed training in MedDRA coding and medical narrative writing for SAE reports.
  • Expertise in regulatory report writing like ISS/ISE, ICSR, PSUR, PBRER, SUSAR, aggregate reports and others as required for various regulatory compliance.
  • Capability for conducting pharmaco-epidemiological Phase IV studies.
  • Evolve and implement risk management practices.
  • Competency to handle pharmacovigilance audits.
  • Soft Skills development.

Syllabus

  • Drug Development Process
  • Ethics of Human Subject Protection
  • Good Clinical Practice in Clinical Trials
  • Ethics, Honesty, and Business Dynamics at Play
  • Understand Drug Safety Department
  • Training in Drug Safety Career for New Hire
  • Pharmacovigilance and regulatory needs
  • US FDA: Regulatory Scenario
  • Europe, ICH, CIOMS, and International Regulatory Scenario
  • Adverse Events Reporting and Post-marketing Activities
  • Adverse Event evaluation Seriousness, Expectedness & Causality
  • Understand the Role of MedWatch Form and Importance of Patient -Reporter Details in ICSR
  • Importance of Event Details in ICSR and Importance of Product Details in ICSR
  • Dynamics of AE Reporting
  • Need to Follow-up and Completion of Reports and Importance and Significance of Voluntary Reports
  • The course provides training to the students on the features of Argus Safety, its role in fulfilling the pharmaceutical industry’s toughest regulatory challenges, and how it supports drug safety business processes from an easy-to-understand user interface.
  • Thorough case processing and discussions will allow students to gain skills regarding handling different types of cases, case processing in the software, and the highest possible quality standards to support accurate detection and analysis of drug safety signals.

INTERNSHIP

Duration: 12 weeks

Why Oracle Argus?

Oracle Argus Safety is an end-to-end comprehensive safety processing database used for global case processing, periodic and expedited reporting, and detailed analytics.. Pharmaceutical companies all across the world process cases using Argus safety database to ensure global regulatory compliance, effective and fast safety data entry, and risk management needs.

Internship Program:

Using Oracle Argus 8.1.2 Safety Software, students achieve practical experience in processing ICSRs from book-in to distribution. The purpose of the internship is to expose students to an on-the-job-experience where students are given an opportunity to work with live cases. This is unlike the classroom setting as students do not have access to the cases beforehand and this enables students to virtually experience the challenges faced by Drug Safety Associate, Drug Safety Specialist, PV associate, PV specialist, Clinical trial safety associate, and clinical safety speciality in the field. They develop the ability to extract relevant information from varied sources to triage the assigned cases into serious or non-serious and process cases to industry standards. They will handle the full gamut of live industry cases provided by the faculty to develop critical analysis and judgment, independent decision making, case assessment capabilities, case interpretation, data presentation and Medical writing skills. Students gain hands-on experience of working on coding for medical history, ADRs using WHO drug dictionary, and MedDRA. They process all types of cases that include literature, valid, spontaneous, clinical trials, invalid, serious, non-serious, at risk, and lack of efficacy cases.

 

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

5-7 Months 

Engagement

300 hours

For information regarding fee and/or reserving your spot, contact our Admissions Team.

Credit transfers applicable for alumni

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.

Campus Visit

FAQs

This is a 300 Hour program

  • Bachelor in Health Care or Life Sciences background

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.

Yes. Internship provides an excellent opportunity for practical hands-on working experience on virtual life like functionality of various Reporting functions for Drug safety and Pharmacovigilance.

Certificate of Completion in Advanced 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.