Careers in Clinical Research

March 20, 2008

Drug Safety and Pharmacovigilance

Filed under: CDER, drug safety, EMEA, FDA Regulation, pharmacovigilance — clinnovo @ 3:10 pm

The ground truth of how pharmaceutical industry has evolved over the past decade is the large surge in increased specialization and sophistication. In this series we will focus on specialist careers in pharmaceutical industry, lets start with pharmacovigilance.

No medicine which is effective is 100% safe, but the adverse/side effects of a drug have to be weighed against the benefits of the drug. For example a drug treating terminal disease like cancer can have some adverse effects like vomiting and hair loss, but still it would be approved given the gravity of disease it is used to treat. Drug safety function focuses on measurement, prediction, reporting and evaluating safety signals. There are several roles in this domain namely :

  • Drug safety physician
  • Safety specialist
  • Safety informatics expert
  • Safety information expert

If you are good at either synthesising medical information/research finding or have great analytical capabilities to drill down into complex safety data this area of specialization is very suitable and lucrative for you.

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