Master of Science 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

With a surge in the advancements of the pharmaceutical industry, regulatory authorities are constantly striving to safeguard the public health, striking a fine balance between the promising benefits of drugs and varying levels of suspicion about the potential harm making Drug Safety & Pharmacovigilance necessary.

In This Course

Learn fundamental topics such as Regulatory Compliance for Drug Safety and Pharmacovigilance; and Risk Management, Signal Evaluation, and Reports, and the successful navigation of drug safety and pharmacovigilance as keys to product longevity, consumer confidence, and regulatory compliance.

The Sollers Advantage

This Master’s program in Drug Safety and Pharmacovigilance by Sollers is taught by faculty with experience in the industry. Get hands-on experience working with the latest tools in the industry such as SAS JMP Clinical and Oracle ArgusEmpirica.

Learning Outcomes

  • Develop an advanced working knowledge of the role of the Drug Safety Associate.
  • Develop proficiency in the use of the Oracle Argus Safety software that is a crucial, and often mandatory, skill in today’s job market.
  • Develop a comprehensive knowledge and understanding of the FDA, EU-EMA, and ICH regulations for drug safety and pharmacovigilance.
  • Develop a strong working proficiency in writing regulatory reports.
  • Through hands on experience develop a working proficiency in medical narrative writing for SAE reports.
  • Learn to properly conduct Pharmaco-epidemiological Phase IV studies.
  • Develop an understanding of the proper procedure for success in pharmacovigilance audits and of basic risk management as it relates to the pharmacovigilance industry.

Syllabus

  • Introduction to Drugs, Safety and its Regulations
  • Regulatory Compliance for Drug Safety and Pharmacovigilance
  • Adverse Events Reporting and Post-Marketing Activities
  • Introduction to Oracle Argus Safety Application Part I
  • Basics of Biostatistics and Epidemiology
  • Literature Review
  • Project Management
  • Advanced Drug Safety Vigilance
  • Organization and Functions of Drug Safety Department
  • Introduction to Drug Safety Physician Functions: MedDRA, ADR, Narrative Writing Part I
  • Drug Safety Physician Functions in Pharmacovigilance:
    Narrative Writing Part II
  • Oracle Argus Safety Application Part II
  • Signal Detection Using Empirica
  • Signal Detection Using JMP Clinical
  • Analytics in Pharmacovigilance
  • Risk Management, Signal Evaluation, and Reports
  • Recent Advances: REMS, Action and Drug Withdrawals
  • Capstone Project

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


Prachi Chandel

Faculty of Drug Safety and Pharmacovigilance


Course Duration

Duration

2 Years 

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.

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.

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

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

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)