Pharmacovigilance/safety: the unsung hero of pharma and arguably the most applicable to our pharmacy expertise. Pharmacy school trains us to be the final verifiers of safety before medications are in the hands of patients. Safety and risk management involves looking at what happens after administration. By analyzing cases from sources such as clinical trials, literature, and postmarketing data, safety scientists work to identify adverse events, determine causality, and if applicable – mitigate the risk. It is sort of like playing detective but instead of finding the criminal, you’re working to determine if a crime was even committed. If an adverse event (“crime”) did occur, what can we do to ensure it does not happen again, lower the frequency of occurrence, or lessen the intensity of the event? When an adverse event of particular interest (observation/alert) is determined to be related to the study drug, it is validated as a Signal, which is then either verified or refuted as a risk. Verified signals are characterized to determine the appropriate response, which could be anything from updating the medication label to listing it in the Risk Management Plan. There is plenty of opportunity to work cross-functionally with Drug Safety Operations, Drug Safety Epidemiology, Clinical Development, Regulatory Affairs, and Medical Affairs as safety and risk management teams will usually include 1 representative from each functional area. Listed below are a few responsibilities of safety scientists:
Signal detection and management activities including review of individual case safety reports
Interpreting and presenting safety data in internal forums to cross-functional teams
Supporting authorship of aggregate safety reports such as Periodic Benefit-Risk Evaluation Reports (PBRERs), Drug Safety Update Reports (DSURs), and Risk Management Plans (RMP)
Conducting literature reviews to identify new safety information