Pharmacovigilance Course Training Center

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Pharmacovigilance Course training in Hyderabad provided by GenSol Healthcare. 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.
Pharmacovigilance is a field of science that primarily deals with determining, verifying, quantifying, analyzing and reducing the ill effects of medical drugs, devices or biologicals, thus increasing their safety. Pharmacovigilance is an anchor throughout the life cycle of new drugs and devices due to a demand screated by the requirement of new medical treatments and their legislation.
The Pharmacovigilance training & internship provided in GenSol Healthcare equips the students to gain expertise in order to deliver efficient functioning in the organization that they are a part of. GenSol Healthcare 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 eventcase, 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.
At GenSol Healthcare we transform students interested in pharmacovigilance into seasoned professionals up-to-date with the most recent knowledge and trends. The Advanced Pharmacovigilance course is practically driven and structured on the responsibilities expected of a pharmacovigilance professional in the drug development industry. Candidates enrolled in this highly focused pharmacovigilance program is equipped with the knowledge of the global regulatory landscape and acquire skills necessary for regulatory strategic planning throughout the product life cycle.

Pharmacovigilance Course Training Content & Syllabus & Modules

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

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