Graduate Certificate in Drug Safety and Pharmacovigilance Training 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 Drug Safety and Pharmacovigilance Training 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 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. Students gain thorough understanding of the adverse events and adverse drug reactions (ADRs), AE evaluation,dynamics of AE reporting, medwatch forms, and ICSR processing.Students are given full fledged knowledge and access to Oracle Argus Safety database along with sample cases.
The Sollers Advantage
The highlight of this program is the hands-on access to the latest and high in-demand safety database tool used by the pharmaceutical industry, Oracle Argus 8.1.2. Our Program provides practical experience of using the Argus Safety database. The 3-month certificate course is designed and taught by faculty with experience in the industry.
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.
- Curriculum: Job-oriented, industry-based curriculum, full-fledged access to program content, batch recordings, and tools up to one year of program completion.
- Certification: Students will receive course 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
This course is based on the FDA guideline on Good pharmacovigilance practices (GVP) and is a complete training solution to acquire pharmacovigilance knowledge.
Gain expertise in Clinical Research, Drug Development, Clinical Trial Design and Clinical Development.
Understand the FDA, EU-EMA, and ICH regulations for drug safety and pharmacovigilance.
Develop advanced knowledge of various functionaries in Drug Safety departments.
Practice the processes of triage, data entry, medical review, Phase IV surveillance trials, as well as reporting through the Oracle Argus software.
Detailed training in MedDRA coding and medical narrative writing for SAE reports.
SYLLABUS
To get the complete syllabus, please login with your email ID.
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.
Course Duration
Duration
3-4 months
Engagement
150 Hours
For information regarding fee, contact our Admissions Team.
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
FAQs
This is a 150 Hour program
Basic knowledge to work with Computers, quick learning aptitude to get trained in newer software application tools like Oracle Argus Safety, Get trained on company SOP, Medical terminology, Clinical SAS, willing and ready to acquaint with changing regulatory landscape in Pharmacovigilance.
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.
Certificate of Completion in 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.