Program Overview

The Advanced Drug Safety and Pharmacovigilance program is a unique, job-oriented training that provides a comprehensive understanding of drug safety and risk management throughout the drug development process and its lifecycle in the market. This program prepares students to understand various adverse events and their correlation with systemic abnormalities, known as Adverse Drug Reactions (ADR). It also enhances analytical skills to differentiate between disease progression and ADRs. Additionally, the program covers regulatory issues from global agencies like the FDA, EMA, and ICH to improve safety.
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Oracle Argus Internship

Elevate your skills with our 12-week in-house internship and master the latest highly demanded must-have tool, Oracle Argus 8.1.2!

Career Support

Experts with over 15 years of professional industrial expertise guiding and coaching students to polish their resumes and prepare for interview success!

Lineage of a decade

For more than 10 years Sollers college has been paving the way for education offering top notch insightful programs along with a broad alumni network for engagement.

Learning Outcomes Of This Program

  • 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.
Medicine is not only a science; it is also an art. It does not consist of compounding pills and plasters; it deals with the very processes of life, which must be understood before they may be guided.
- Paracelsus

COURSE 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, its features, functionalities, and practical applications.

Internship Program

Our 12-week internship includes training in Oracle Argus Software and Aggregate Reporting, allowing students to gain clinical field experience and be job-ready from day one.

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 resume and interview preparation, along with references for jobs as a Clinical Research Intern and a Drug Safety Associate Intern.

Program Requirements

  • This program is designed for professionals aspiring to make a career in Drug Safety using the Oracle® Argus Safety software.
  • Professionals with backgrounds in Medicine, Pharmacy, Nursing, Life Sciences, and Health Sciences will benefit the most from this program.
  • 20 Credit; 300 Hours; 3 Session /week for 15 weeks (20+ hours each week).
  • Sollers College, Unit 1850, 55 Parsonage Road, Edison, NJ - 08837.
  • Live Online Sessions via Microsoft Teams.

Unlock Your Potential in
Drug Safety Today!

About Sollers College

Established in 2007, Sollers College is a pioneering institution offering industry-focused professional learning programs in information technology and life sciences. Sollers collaborates with businesses to identify their unique requirements, develop tailored courses, and provide ready-on-day-one employees at a low cost. Beyond degrees, Sollers ensures graduates are job-ready through comprehensive Career Services and strong industry collaborations, assisting students throughout the job-search process.

Vision Statement

Our top priority goal at Sollers college is to nurture, mentor and guide students providing them with the necessary tools in order to be at the forefront of clinical research, pharmaceutical discovery and technological advances. We at Sollers also aspire to be among the nation’s leading educational institutions of our pre-eminence in emerging programs, excellence in teaching and commitment to the community.

Mission Statement

Soller’s main mission is to equip students with first rate knowledge and with the necessary valuable skills needed for employment and career advancement.

Testimonials

Frequently asked questions about choosing a career in Drug Safety and Pharmacovigilance

  • Is there a high demand for Pharmaceutical and drug safety specialists?
    Yes, there is a high demand for Pharmaceutical and drug safety specialists and in fact there is a higher demand than ever before!
  • What's the key to maximizing the value of a medical/life sciences background?
    Leveraging your medical/life sciences background (education and experience) to the best.
  • How will my work-life balance be after taking up a career in pharmaceuticals in drug safety?
    This shouldn’t be a problem as a career in pharmaceuticals in drug safety as it offers a better work-life balance and plus there are plenty of remote roles at your availability too!
  • What are the main advantages after taking up this career path?
    There are mainly two advantages that come with choosing this career path. Firstly, there is a great potential for growth in career both in terms of learning and remuneration. Secondly, the opportunity to work with pharmaceutical giants who are leaders in cutting edge innovation and research.
  • Does choosing this course have an impact on society?
    For sure! With the recent surge in demand for the pharmaceutical and drug safety professionals, choosing a career in Drug Safety and Pharmacovigilance gives you an opportunity to give back to the society and make a difference.
  • How much does the Advanced Drug Safety and Pharmacovigilance course at Sollers cost?
    The cost to enroll in the Advanced Drug Safety and Pharmacovigilance course at Sollers is $7,500.

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