Graduate Certificate in Advanced Drug Safety and Pharmacovigilance 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.

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 Advanced Drug Safety and Pharmacovigilance 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 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, regulatory issues across global governmental agencies like the FDA, EMA, ICH, and others. This program educates students about the business dynamics of the pharmaceutical industry. Students gain a thorough understanding of adverse events and adverse drug reactions (ADRs), AE evaluation, AE reporting dynamics, MedWatch forms, and ICSR processing. Hands-on 12-week internship training on the industry-based Oracle Argus Safety database. In the internship, students develop the ability to triage the assigned cases according to industry standards.

The Sollers Advantage

The highlight of this advanced program is the 12-week In-house Internship on the latest high demand tool, Oracle Argus 8.1.2. Students work in different roles in our internship program 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.

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.,and  CTMS & ETMF tools based on elective selection.

Internship Program: 12-week internship program in Oracle Argus Software.

Curriculum: Job-oriented, industry-based curriculum aligned with the current scenario with full-fledged access to program content, batch recordings, and tools after one year of program completion.

Certification: Two certificates – a course completion certificate and internship completion.

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

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

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. And work on real time live cases.

Hands-on experience of working on coding for medical history, ADRs using WHO drug dictionary and MedDRA.

Expertise in regulatory report writing like ISS/ISE, ICSR, PSUR, PBRER, SUSAR, aggregate reports and others as required for various regulatory compliance.

SYLLABUS

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    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.
    • 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

    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.