Imagine this all-too-common scenario. You are the head of a mid-sized pharmaceutical company and one of your most successful post-marketed drugs is up for its annual Periodic Adverse Drug Experience Report (PADER). Upon draft of this required annual report, you learn that there are multiple “safety signals” that were missed throughout the year. What you thought would be a routine PADER now involves a complex and confidence-eroding situation where your firm has to answer for