Masters’ in Drug Safety and Pharmacovigilance

Work with the latest industry tools and learn how to apply them in the domain of Drug Safety and Pharmacovigilance.

OVERVIEW

Why Drug Safety and Pharmacovigilance

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. With a surge in the pharmaceutical industry’s advancements, regulatory authorities there is a growing need for qualified professionals for the pharmaceutical industry, regulatory authorities, and academia.

In This Course

Students will gain a thorough understanding of E2E Pharmacovigilance processes, Concepts of the drug life cycle, Guidelines and regulations, adverse events and adverse drug reactions (ADRs), aggregate reporting through Oracle Argus 8.1.2 Safety database application, Project Management, and Literature Review, Internship in Oracle Argus Software, Electronic Trial Master File documentation (eTMF) tool, CTMS, and Capstone Project.

The Sollers Advantage

  • E2E comprehensive program that covers PV concepts and  clinical research
  • Access to Oracle Argus Safety database 8.1.2, CTMS and ETMF systems based on elective selection
  • During their internship sessions for all types of cases, students work in several positions simulating Pharmaceutical roles.
  • Capstone Project during the final semester to demonstrate a practical understanding

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: Internships in PV and Clinical Trial Management based on elective selection.

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 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

  • Students gain a thorough understanding of the adverse events and adverse drug reactions (ADRs).
  • Training for triage of Adverse Events and Serious Adverse Event, aggregate reporting through Oracle Argus 8.1.2 Safety database application.
  • Know the process of coding with MedDRA and medical narrative writing.
  • Hand on experience on Oracle Argus Software.

Syllabus

Register now, to get the complete syllabus.



    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

    2 Years 

    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

    FAQs

    The program can be completed in 15 months.

    You must have a bachelor’s degree to apply to the program. We recommend an undergraduate degree in life sciences, health science, pharmacology, nursing and medicine. Students with a professional background in nursing, medicine or pharmacology can leverage this degree for accelerated advancement in the in Pharmacovigilance and Drug Safety field.

    Students may receive up to 16 credits for their work experience. If you think your work experience may qualify, talk with one of our advisors.

    The masters program can be taken over 4 semesters with 36 required credits.

    Tuition is $1,000 per credit hour.

    A Capstone Project is an independent project that allows students to pursue research on the topic of their choice.

    It is a project-based activity that relates to professional work. With the guidance of a mentor, they create a significant paper that reflects a deep understand of that particular topic.

    Yes. Sollers is an Oracle University Partner and an SAS Academic Partner. As a result, you receive hands-on experience either in Signal Evaluation with SAS JMP Clinical and Oracle Insight, Analytics, Argus and Empirica OR MedDRA coding and medical narrative writing for SAE reports.

    Please submit the inquiry form on this page to receive more information about the Sollers College Master’s in Drug Safety and Pharmacovigilance.

    Submissions of assignments, quizzes, and surveys along with financial obligation towards the college is mandatory for processing and issuing of certificate

    Industry Facts

    • Drug Safety gives you an opportunity to use your medical skills in a lucrative career with Pharmaceuticals.
    • $120K salary as a Drug Safety Physician with 2-3 years of experience -Indeed.com
    • $146K as a Medical Reviewer with 2-3 years of experience -Indeed.com
    • Potential to make up to $200K+ as a Director of Drug Safety with 5+ years -Indeed.com
    • 33,000 jobs available, but demand for trained professionals are not being met -Indeed.com
    • Immense career growth experience.

    Drug safety jobs and pharmacovigilance positions are found throughout the medical industry. A career in drug safety and pharmacovigilance will generally start with a position as a drug safety associate, officer, scientist or coordinator. Responsibilities will then progress to senior specialist or management roles, often with an in-depth knowledge of a specialty area, such as medical writing, auditing, medical affairs or quality assurance. In most cases, somebody working in a drug safety or pharmacovigilance function will earn a yearly salary of between £25,000 and £60,000.

    Importance of drug safety. (READ MORE)

    Establishing strict laws by regulatory bodies such as DCGI, US-FDA, EMEA etc. has directed to the adoption of a methodical Pharmacovigilance structure worldwide. This change had brought to the creation of huge number of job opportunities related to this sector. Average Pay-scale of Pharmacovigilance Professionals

    USASouth AfricaSingaporeIndia
    Entry Level$67,000R205,614S$42,833INR264,000
    With 4-5 Years Experience$98,000R439,773S$80,427INR650,000
    More than 8-10 Years Experience$136,000R845,833S$192,528INR14,000,00

    The GVP and CIOMS guidelines and the recently issued US FDA guidelines provide guidance to the pharmaceutical and medical device industries to screen internet or digital media under their management or responsibility, for potential reports of suspected adverse reactions.
    The impact of social media on drug safety (READ MORE)