Advanced Drug Safety and Pharmacovigilance

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

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

Besides practical exposure, this program will focus on the regulatory issues across global governmental agencies like the FDA, EMA, ICH, and others that improve safety and help deeply understand Adverse Drug Reaction (ADR).

The Sollers Advantage

The special features in this advanced course include an internship where the students can work on real cases and gain competency to take necessary roles and responsibilities along with handling pharmacovigilance audits.

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.
  • 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.
  • Internship in Oracle Argus Software.
  • 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

Using Oracle® Argus Safety software, students will 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.

This is a 12-week internship.

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

5-7 Months 

Engagement

300 hours

For information regarding fee and/or reserving your spot, 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.

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.