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Pharmacovigilance Academic Module

Offers access to live pharmacovigilance application for those aspiring candidates who really want to make a difference with their presence in pharmcovigilance industry

Pharmacovigilance discipline has already emerged as a distinct department/global cell altogether. Presently, there are ample openings as the demand for the trained pool is high and the supply is scarce.

Currently, many courses are being offered for Pharmacovigilance training with a view to increase the number of trained candidates for accomplishing the Industry requirement. However, there is a dearth of practical aspects included in these academic training to mold students into competent professionals.

The course curriculum in addition to theoretical pharmacovigilance training fundamentals and guidelines should comprise of stringent practical work hours. Without having practical exposure, it is difficult for a trainee to be absorbed in an Industry that is techno-savvy and highly advanced as far as operational pharmacovigilance skills are concerned.

Why PvEdge?

Sarjen offers access to live pharmacovigilance training application – PvEdge to those aspiring candidates who really want to make a difference with their presence in this Industry. Undoubtedly, pharmacovigilance has a vast range of activities for which simply manual training won’t be self-sufficient.

The practical aspects covered through PvEdge would include

  • ICSR processing and management.
  • Expedited submissions in different report formats.
  • Automated literature monitoring.
  • Generating line listings and reports for aggregate safety submissions.
  • Follow up & Versioning
  • Procedural aspects like duplicate search, case creation, data entry, nullification of cases, case narrative writing with pre-defined narrative templates, and merger & deletion activities.
  • Real-time coding of data for case submission.
  • PV workflows as per current Industry practices.
  • Wide platform with various product categories e.g., medicinal products, vaccines, medical devices etc.

Benefits of a tie-up with 'PvEdge – An Academic pharmacovigilance training module'

  • A database that is in use by Industry giants.
  • Regulatory (21 CFR Part 11) compliant solution access and use.
  • Candidates will have a fair idea of pharmacovigilance activities in a large-scale setting.
  • Better clarity on PV guidelines due to direct software access and hands-on training.
  • Higher placement rates – Practical training reinforces the theoretical aspects making it easier for trained students to be well-positioned in Industry.
  • Other pharmacovigilance softwares are too expensive to fit into the academic model, PvEdge offers a cost-effective approach to train the aspiring candidates on a real time PV environment.
  • Flexible training options to suit the course curriculum in parallel or later post-theory understanding.
  • Value-addition to overall course enhancing credibility and offering long-term benefits to Institutes.