Study of drug safety and the serious adverse events (SAEs) of drugs is commonly known as pharmacovigilance and off-late it has become a very interesting topic within the pharmaceutical industry. In the newly published FDA document explaining strategic goals for 2011-2015, FDA Commissioner explained:
We are in the starting of a new period for drug safety where preserving public health implies that FDAs liability does not end when we provide a drug market acceptance; that is just the initial check point in providing safety.
Drug Safety Physicians Role in Protecting Peoples Health
The safety profile of a new therapy throughout and even at the end of phase I, phase II and phase III clinical study screening is not fully identified. In human studies at most a few thousand subjects are subjected to the new therapy and the number is even lesser in clinical trials of orphan drugs where only a few hundred or may receive the study drug. From a statistical perspective, if 1,000 individuals in the clinical studies who were subjected to the new study drug did not have a cardiac arrest, then the investigator can safely assume that the real occurrence of cardiac arrest with the test drug are less than 1 in 333 subjects.
So obviously the role of the Drug Safety Physician who evaluates the safety information is crucial and needs to supplement the initiatives of the clinical research doctors handling the clinical development plan who are obviously focused on effectiveness measurements.
In clinical studies, the researchers are expected report all Serious Adverse Events to the sponsor within 24 hours of the incident. The sponsor company then classifies the reports based on whether the events where related or not related to the study drug. If related, the events quickly reported to the applicable regulatory authority like FDA, DCGI, and MHRA etc. The company is expected to aggressively monitor, follow up and evaluate all safety problems and adverse events observed while in the clinical studies. This is where the Drug Safety Physician performs a significant role. Drug Safety Physician should look at all the undesirable events and see if there is a design or a pattern in the reports. This is called signal detection.
Some situations are extremely likely to be because of drug while others are equivocal and some especially individuals with a higher background occurrence such as myocardial infarctions, obese diabetics are difficult to ascribe to a drug effect.
This is where the safety physician has to perform important role and evaluate all the information, usually case by case, to search for the needle in the haystack. He/she should know the background of a number of drugs, be a logical thinker and be capable of coming to reasonable and defensible results dependent on unfinished data or on blinded cases.
Looking for Career in Drug Safety?
If you want to explore a career in Pharmacovigilance, you should have thick skin i.e. be able to ignore personal criticism, have proper training in Pharmacovigilance, and good understanding of the clinical research process. Mostly MNCs prefer well trained physicians for a drug safety profile. Obtaining a Diploma, PG diploma or a Certificate in Pharmacovigilance will be added advantage for freshers who want to enter into the Pharmacovigilance profession.
A two year work experience in drug safety can develop you into a well known industry physician. Working in drug safety for a prolonged period of time, will get you promoted as a specialist. Developing a career in Pharmacovigilance is highly rewarding as you can eventually reach senior management positions such as Head of Drug Safety, Director of Pharmacovigilance etc. with excellent compensation packages.
Average Pay Scale of Drug Safety Associates in Different Countries
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