Pharmacovigilance


A pharmacovigilance professional is typically involved in collecting, monitoring, processing and reporting adverse event reports. They follow-up with reporters to gain more details on case reports, and also provide information of product safety to patients and health care professionals. They act as the in-house safety resource in connection with safety issues.

The Pharmacovigilance training & internship provided equips the students to gain expertise in order to deliver efficient functioning in the organization that they are a part of. puts more emphasis on ICSR, PBRER, ADR, MedDRA and case narrative during the training on pharmacovigilance. It develops in students the potential to identify the nature of a suspected adverse event case, identify obstacles and work to resolve it in the predetermined timeline. It also develops analytical expertise in understanding the case processing flow of reported AEs and the latest update of the case with current available information.

Course Modules:

  • Introduction to SAS in Clinical Research
  • Introduction to Pharmacovigilance
  • Clinical Development process
  • Responsibilities :USFDA, CDSCO
  • Pharmacovigilance in India
  • Drug Safety in clinical trials and post marketed drugs
  • Different sources of Adverse events reporting
  • Different types of AE reporting Forms
  • Adverse events and its types
  • Expedited reporting and its timelines
  • Four minimum information for a reportable case
  • Seriousness criteria of adverse event
  • Expectedness ( Listedness) of adverse event
  • Causality assessment of the adverse event
  • Case Narrative writing
  • Case processing
  • Periodic Safety Update Report (PSUR) and its submission timelines
  • Roles & Responsibilities in a CROs & Sponsor in Pharmacovigilance
  • Medical Dictionary for Drug Regulatory Activities - MedDRA
  • Overview of Oracle Argus

During the training period the following modules will be covered as a part of Student career Improvement Program.

  • Communication and Soft skill development
  • Just A Minute Sessions
  • Seminars
  • Case studies
  • Mock interviews
  • Guest lectures
  • Student improvement program
  • Professional career building
  • Organizing Resume
  • Knowledge Sharing on new techniques