Drug safety specialists are leading players in a field known as pharmacovigilance — that is, the science of collecting, detecting and preventing adverse effects (AEs) in patients who take new drugs and other pharmaceutical products. As such, not surprisingly, there’s some overlap between the work of these safety pros and that of clinical research associates (CRAs).
Diving a bit deeper into the role, high-level responsibilities of most drug safety specialists today tend to include:
- reporting on quality control (QC) and routing cases to appropriate workflows
- conducting various QC activities related to drug development and clinical trials
- working with contract research organizations (CROs)
- assessing, processing and entering key data around adverse event (AE) case types
- conducting medical reviews, reading safety reports and working with drug safety databases
- triaging case types to support proper prioritization
- identifying AEs and labeling them appropriately for subsequent case assessments
- determining the appropriate type of reported causality
- coding based on MedDRA, WHO Drug and various product dictionaries
- writing required narrative texts for medical orientation
- determining key follow-up requirements
- proactively supporting inspections and audits with regulatory affairs groups
- supporting drug screenings and adverse event reporting as part of safety management programs
how do you become a drug safety specialist?
There are any number of different paths to becoming a drug safety specialist today, but probably the most reliable begins with the right education and training. That said, there’s no replacement for hands-on learning through doing, as the following requirements make clear:
- a bachelor’s or master’s degree in life sciences, healthcare or a related field
- anywhere from five to seven years of previous experience in the pharmaceutical or biopharmaceutical space, and a minimum of three to five years in drug safety operations (DSO)
- previous experience working with CRO teams
- previous experience in pharmacovigilance inspection with the U.S. Food and Drug Administration (FDA) often preferred
Scan the job description closely to be sure you understand all of the “must-have” versus “nice-to-have” qualifications for the role. You can still land an interview as long as you fulfill all of the latter.
what are the key skills of a drug safety specialist?
Drug safety specialists tend to have fairly diverse skill sets. Beyond having mastered the essential industry lingo, acquired nuanced knowledge of processes and learned how to navigate a heavily regulated space, they also have to work with large teams of people day in and day out. So it’s easy to see why relationship management and team-building skills can be crucial differentiators for candidates.
However, those aren’t the only soft skills that matter. A few additional aptitudes that can really set candidates apart:
- analytical and critical thinking
- strong verbal and written communication skills
- people management and interpersonal skills
- trust- and team-building abilities
- emotional intelligence (EQ) and empathy
- organization and time-management skills
- troubleshooting and problem-solving abilities
what's the pay rate for a drug safety specialist?
Compensation levels for drug safety specialists tend to vary considerably, but six-figure salaries — at least for some of the most seasoned pros — aren’t unheard of. Looking at the latest data, in any case, average salaries for clinical research associates can be effectively grouped into three tiers: low, middle and high. Those tiers are as follows:
Like a lot of things in the economy right now, of course, salaries for drug safety specialists are very much in flux. Your best bet for getting insights, given that context, is to head on over to our free salary comparison tool. It’ll surface at-a-glance data about pay rates across locations and markets.
At this point, you should be pretty well versed in what drug safety specialists do on a daily basis, as we've taken you step-by-step through:
- what drug safety specialists do
- background, training, experience and other requirements for this position
- key skills
- and more
Got it all? Good! Now, it's time for you to take action. Start searching for highly in-demand drug safety specialist positions right now.