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 is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problems” – As defined by WHO. This best explains the importance of pharmacovigilance in the patient’s safety and the use of medicines. Therefore, 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 are always striving to safeguard the public health, striking a fine balance between the promising benefits of drugs and varying suspicion about the potential harm. There is a growing need for qualified professionals for the pharmaceutical industry, regulatory authorities, and academia.

Sollers College’s Master of Science in Drug Safety and Pharmacovigilance Program caters to the needs of this ever-growing and highly regulated industry by offering a curriculum that is highly competent and in alignment with the real-time requirements from the pharmaceutical industry’s point of view. The Master of Science in Drug Safety and Pharmacovigilance program is well-suited for students with a strong background in medicine, dentistry, pharmacy, nursing, biostatistics, information technology, or a degree equivalent to the above in another subject and a portfolio demonstrating suitability for study.

 

In This Course

Students will gain a thorough understanding of:

  • E2E Pharmacovigilance processes, right from drug development processes to processing of different types of live cases, the regulatory issue and requirements across global government agencies that improve safety by covering topics such as Regulatory Compliance for Drug Safety and Pharmacovigilance; and Risk Management, and reports
  • Concepts of the drug life cycle – from preclinical development and drug development processes to post-market surveillance, regulatory compliance for drug safety and pharmacovigilance, risk management, signal evaluation, and report
  • Guidelines and regulations for drug safety and pharmacovigilance principles and operations such as WHO guidelines, FDA guidelines, EU good pharmacovigilance guidelines, CIOMS, and ICH regulation
  • The pharmaceutical industry’s business dynamics and the ethics, structure, function of the drug safety department, and training. Students gain a thorough understanding of the adverse events and adverse drug reactions (ADRs), post-marketing activities, reporting guidelines, AE evaluation, seriousness, expectedness, causality, and AE reporting dynamics, MedWatch forms, and ICSR processing.
  • Training for triage of Adverse Events and Serious Adverse Event, data entry, processing of ICSRs from various sources such as a clinical trial, post-marketed and literature, review and reporting, and aggregate reporting through Oracle Argus 8.1.2 Safety database application
  • Create periodic benefit-risk evaluation reports, pre-approval reports, including IND annual reports and IND annual safety reports, and post-approval periodic experience reports.
  • Process of coding with MedDRA and medical narrative writing in general, as well as the ADR of various systems
  • Project Management and Literature Review
  • Clinical Research Processes and clinical trial management modules that deal with all aspects of clinical trials
  • Internship in Oracle Argus Software – In this 12-week internship phase, students achieve practical experience in processing ICSRs from book-in to distribution and writing case narrative using Oracle Argus 8.1.2. They are given exposure to various real-time, live cases like serious, non-serious, at risk, lack of efficacy cases, literature, spontaneous cases, invalid cases, and clinical trial cases. They also get hands-on experience of working on coding for medical history, ADRs using the WHO drug dictionary and MedDRA
  • During the Internship, students work as drug safety associates, drug safety specialist, pharmacovigilance associate, pharmacovigilance specialist, clinical trial safety associates, and clinical safety specialist, aggregate reporting analyst to acquire knowledge and career readiness
  • Elective 1: Drug Safety Physician Functions focusing on MedDRA, ADRs, and Narrative Writing
  • Elective 2: Hands-on 20+ week internship training in Clinical conductor tool and Electronic Trial Master File documentation (eTMF) for Clinical Trial Management along with Risk Evaluation and Mitigation Strategy (REMS) and Risk Management Plans (RMPs)
  • Capstone Project – Projects to demonstrate a thorough understanding of PV during the final semester

 

The Sollers Advantage

  • E2E comprehensive program that covers hardcore PV concepts as well as clinical research
  • Access to Oracle Argus Safety database 8.1.2 along with access to CTMS and ETMF systems based on elective selection
  • During their internship sessions for case processing, students work as drug safety associates, drug safety specialists, PV associate, PV specialist, clinical trial safety associates, and clinical safety specialists, aggregate reporting analyst
  • During their internship sessions for clinical trial management, students work as CRC, CRA, CTA
  • They process all types of cases that include literature, valid, spontaneous, clinical trials, invalid, serious, non-serious, at risk, and lack of efficacy cases and acquire knowledge and become job-ready from day 1.
  • Capstone Project during the final semester to demonstrate a practical understanding

WHY SOLLERS – HIGHLIGHTS

Instructors: Our instructors are physicians, pharmaceutical professionals, and Ph.D. holders, having ten years of experience in the pharmaceutical industry and currently working in a pharma company. They bridge the gap between academia and industry by guiding students and providing real-time examples and scenarios.

Software and Tools:

For PV: Hands-on, 12+ weeks internship, provided using the updated industry-based version of Oracle Argus Safety database tool – Argus 8.1.2. They process all types of cases that include literature, valid, spontaneous, clinical trials, invalid, serious, non-serious, at risk, and lack of efficacy cases and acquire knowledge and become job-ready from day 1.

For CTM: Hands-on, 20+ week internship, provided using CTMS and ETMF tools

Internship Program: Our program has two internships based on the elective selection

  • 1. Students work as drug safety associates, drug safety specialists, pharmacovigilance associates, pharmacovigilance specialists, clinical trial safety associates, clinical safety specialists, and aggregate reporting analysts to acquire knowledge and career readiness in our PV internship programs.
  • 2. In our CTM internship program, students work as CRC, CRA, and CTA to gain experience in the clinical trial field.

Curriculum: Job-oriented, an industry-based curriculum that is aligned with the current scenario. Students will get access to the program content, batch recordings, and tools after one year of program completion. This helps in interview preparation and knowledge review.

Certification: Students will receive a course completion certificate after the completion of their internship.

Career Guidance: Students are guided by our Industry faculty with more than 30 years of experience in resume preparation and interview preparation.

References: We provide them with references for the jobs as a Drug Safety Associate Intern upon completing the Academic Internship.

Syllabus

                                                                                                              Credits

Introduction to Drugs, Safety and its Regulations                                 3

Organization and Functions of Drug Safety Department                      3

Regulatory Compliance for Drug Safety and Pharmacovigilance        3

Adverse Events Reporting and Post-marketing Activities                    3

Introduction to Oracle Argus Safety Application        3

Clinical Research in Pharmacovigilance                      2

Literature Review                                                             2

Project Management                                                       2

Aggregate Reporting  3

Electives:

Track – 1: Introduction to Drug Safety Physician Functions: MedDRA, ADR, Narrative Writing Part I     3

Track – 2: Drug Safety Physician Functions in Pharmacovigilance: Narrative Writing Part II                     3

OR

Clinical Pharmacovigilance using CTMS and ETMF                 4

Risk Based Monitoring in Pharmacovigilance                            2

Signal Detection in Pharmacovigilance         1

Capstone Project                                                5

Total Credits                                                36

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.

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

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)