Graduate Certificate in Drug Safety and Pharmacovigilance Training Program

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

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Overview

OVERVIEW

Why Drug Safety and Pharmacovigilance

“Safety isn’t expensive; it is priceless.” Therefore, Pharmacovigilance has become the prime focus in the healthcare industry to optimize benefits and risks. Sollers College’s Drug Safety and Pharmacovigilance Training Programs cater to the needs of this ever-growing and highly regulated industry by offering a curriculum aligned with the real-time industry requirements, highly competent, and equips career readiness for professionals in the pharmaceutical industry.

In This Course

This program provides a thorough understanding of the drug development process and its life cycle, regulatory issues across global governmental agencies like the FDA, EMA, ICH, and others. Students gain thorough understanding of the adverse events and adverse drug reactions (ADRs), AE evaluation,dynamics of AE reporting, medwatch forms, and ICSR processing.Students are given full fledged knowledge and access to Oracle Argus Safety database along with sample cases.

The Sollers Advantage

The highlight of this program 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 experience in the industry.

Highlights

HIGHLIGHTS

  • Proficient Instructors: Experts with 15+ years of industrial experience guiding students and providing real-time examples and scenarios.
  • Software and Tools: Get in-depth knowledge of Argus 8.1.2.
  • Curriculum: Job-oriented, industry-based curriculum, full-fledged access to program content, batch recordings, and tools up to one year of program completion.
  • Certification: Students will receive course completion certificate
  • Career Guidance: Our career service advisors provide guidance for the resume and interview preparation.
  • References: References for the jobs as a Drug Safety Associate Intern

Learning Outcomes

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 various functionaries in Drug Safety departments.

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.

SYLLABUS

To get the complete syllabus, please login with your email ID.


    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.

    Nimita

    Dr. Nimita Limaye

    Faculty of Drug Safety

    shabana-dange

    Dr. Shabana Dange

    Faculty of Drug Safety

    image

    Dr. Jaydeep

    Faculty of Drug Safety

    Santhosh

    Santhosh Sirupa

    Faculty of Drug Safety

    Shaurya

    Prof. Shaurya Chandel

    Faculty of Drug Safety

    prachichandel

    Prof. Prachi Chandel

    Faculty of Drug Safety

    NancyRavuri

    Nancy Pavan Ravuri

    Faculty of Drug Safety

    renu

    Prof. Renu Khurana

    Faculty of Drug Safety

    Course Duration

    Duration

    3-4 months

     

     

    Engagement

    150 Hours

    For information regarding fee, contact our Admissions Team.

    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!

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    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.

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    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.
    • Sampada Lokhande
      “Sollers has great certificate and internship programs in Clinical Trials domain. I have recently completed Clinical Data Science program with Sollers. Their faculty, facilitators, career services all are knowledgeable and experienced in the field of Clinical Trial. I was very happy with the internship program too. They provided me with valuable guidance throughout my program, internship and job application process. I definitely would recommend Sollers.edu to anyone who wants to pursue education in Clinical Trial industry ??”
      Sampada Lokhande

    FAQs

    How long is the program?

    This is a 150 Hour program

    Are there any prerequisites?

    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.

    Why should I do this course at Sollers?

    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.

    Why is this course relevant today?

    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.

    What will be the certification that will be awarded?

    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.