I would like to know what is the day like of a drug safety specialist in a pharmaceutical company. I know that mostly you are reporting adverse events. How do you find adverse events, what is the process? Are you assigned to cases or there is a way to look for them? Any input would be appreciated.
It depends on the size of your company and how much of the drug safety process they outsource. At a high level overview, the process goes like this:
Intake -> Case Processing -> Medical Assessment -> Surveillance
You also have other activities going on such as Periodic Reporting, Risk Management, Compliance, Safety Data Exchange Agreements, Clinical Trial support, etc. but the above flow describes the flow of an adverse event report at the most basic level. Intake refers to the intake of adverse event information, Case Processing refers to entering the information into a safety database and properly coding the adverse events along with narrative writing, Medical Assessment is assessing if the adverse event is expected and related to the drug, and finally Surveillance is the scientific assessment of drug-event pairs from all sources of safety data to determine if there is a causal relationship that would impact the known benefit-risk profile of the drug.
If you are an entry level drug safety specialist, you will most likely be involved in the first 2 steps - Intake and/or Case Processing. You may also be involved in the some of the other activities I mentioned. If you are at a small company, there is a good chance you can get exposure to almost everything as a Drug Safety Specialist.
As for the more specific processes of adverse event intake and processing, I think a forum isn't necessarily the best way to describe them but you can find plenty of resources online.
I guess a very quick example is if a pharmacist calls into the company and reports that they had a patient begin vomiting after taking your company drug. Your job would be to recognize that the report contains the minimum criteria to constitute a valid report and start documenting investigative information while asking questions. You would then figure out which of those events constitute "serious" or "non-serious" criteria, assess whether the events are "expected" according to the label (sometimes done by the physician), and then enter the documented information into the database so it can make sense to the safety scientists (and health authorities). You would also write a narrative telling the "story" of the report. After you are done with the case processing, it would move forward to Medical Assessment (usually physicians) - and then you would do this again for the next report. You may also be responsible for following up with the reporter at a later date to get updated information like if the drug was restarted or did the adverse event resolve. Each company has their nuances and way of assigning caseload. How intake and processing is done affects the quality of the information the safety scientists have to work with during surveillance - the general idea is if you enter in junk, the output will be junk.
In drug safety operations, you will not use much of what you learned in pharmacy school.
