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United States Department of Education in an evidence based meta-analysis of various studies conducted over a period of 12 years concluded that students who acquired higher education through online mode performed much better than those in regular class room courses. (www.ed.gov/about/offices/list/ opepd/ppss/reports.html)

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Careers in Pharmacovigilance & Drug Safety

Drug safety and pharmacovigilance are extremely important functions throughout the development, marketing and continued use of any medication. People in these roles are responsible for monitoring, controlling, processing and reporting the adverse event data obtained from various clinical trials and post-marketing safety. A career in drug safety and pharmacovigilance starts with a position as a drug safety associate, officer, scientist or coordinator. Responsibilities then progress to senior specialist or management roles, often with an in-depth knowledge of a specialty area. Following are some main responsibilities of pharmacovigilance professionals:

  • Attend and accurately document the important telephone calls or faxes from various investigative sites
  • Report adverse events spontaneously and on time
  • Monitoring, collecting and processing the obtained data in a safe database according to the applicable standards, regulations and guidelines
  • Prioritize the event or case according to the applicable guidelines and project requirements
  • Ensuring quality by following various standards, guidelines, regulations and project requirements
  • Completing projects before or on time and within budget
  • Ensure integrity, accuracy and completeness of data
  • Understand and communicate the budget and scope of the assigned project
  • Arranging for various clinical trial investigator and client meetings accordingly

  • Education:

    - Master's or Bachelor's degree preferably in Life Sciences or Pharmacy
    - Excellent knowledge of ICH GCP and regulatory guidelines

    Skills:

    - Strong understanding of ICH-GCP and clinical research process
    - Knowledge of multiple safety databases
    - Goal oriented and meticulous
    - Demonstrate management skills and ability to meet timelines
    - Dedicated with strong sense of responsibility
    - Clear understanding of drug safety
    - Should be abreast with industry trends and compliance
    - Excellent verbal and written communication skills

    Which Course/Program should I choose if I want to become a Pharmacovigilance Professional?

    Programs recommended if you wish to become a Pharmacovigilance Professional are:


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