Pharmacovigilance Academic Module

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 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 training on pharmacovigilance 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.

Sarjen offers access to live pharmacovigilance 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 cases, nullified cases, case narratives
  • Real-time coding of data for case submission
  • PV Workflow as per current Industry operations
  • Wide platform with various product categories e.g., medicinal products, vaccines, medical devices etc.

Benefits of a tie-up with ‘PvEdge – Academia Model’:

  • 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
  • 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