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What's the Role of a Drug Safety Specialist?

Michael Fladger • August 11, 2022

Drug safety specialists are key players in an essential function of drug companies known as pharmacovigilance, the application of data science and machine learning to the detection of adverse events in patients who take new drugs or who are treated with new medical devices. Drug safety specialists are essential in the process of securing FDA approval for drugs in development, and their duties overlap those of research associated both before and after a drug reaches the market.


In the United States, the "average" salary of a drug safety specialist is $82.484 a year. There is considerable variation in the figures reported by the main salary aggregation sites. Salary.com reports the average annual salary of a drug safety specialist as $67,997, but the average annual salary reported on Glassdoor is $104,998.


Salary aggregation sites like Glassdoor, Salary.com, Payscale, ZipRecruiter, and Indeed rely on anonymous data submitted by visitors to their site on the Internet. But the Bureau of Labor Statistics and the National Compensation Survey offer objective information on how much companies pay for drug safety specialists throughout their careers.

  • Entry-level drug safety specialists, with one year on the job or less, earn on average $52,998 per year.
  • Early career drug safety specialists, with one to four years of job experience, earn on average $67,063 per year.
  • Mid-career drug safety specialists, in Years 5 through 9 on the job, earn on average $84,739 per year,
  • Experienced drug safety specialists, with 10 to 20 years of job experience, earn on average $100,521 per year.
  • Late-career drug safety specialists, who have been doing the job for 20 years or more, receive an average of $119,170 per year.


Location of employment makes a big difference in compensation. The average annual pay for drug safety specialists of all levels of experience is just $70K to $75K in Tampa, Miami, and Indianapolis, but the average pay in Boston and Los Angeles is $100K per year, and in San Francisco it is $118K.


Drug safety specialists don't earn as much as clinical pharmacists or pharmacy managers, but they earn more than registered nurses and research associates. They earn more than twice as much as medical assistants, pharmacy technologists, or coders.


What Does a Drug Safety Specialist Do?


The day-to-day duties of a drug safety specialist span a variety of skills. Drug safety specialists write narrative texts for medical orientation. They determine appropriate WHO Drug, MedDRA, product dictionary codes to compare data across clinical experiences. They triage cases for appropriate analysis. They identify and label adverse events for subsequent assessments.

A drug safety specialist may be assigned to work with a contract research organization to collect, process, and assess key data around adverse events. The drug safety specialist will read and write safety reports, create and work with drug safety databases, and conduct medical reviews. They proactively support audits and inspections from the FDA and international health regulatory agencies to ensure the marketing success of their company's products.


How Do You Qualify for a Drug Safety Specialist Job?


There is no set path for a drug safety specialist position, but the surest way to get the job you want is to have the right combination of formal education and on the job experience. Fladger Associates can help!


Most successful candidates will have a bachelor's and/or master's degree in the life sciences and/or data science and statistics. The ability to integrate machine learning and data science into the processing of adverse event data is highly valuable in the job market.

Nearly all successful applicants for drug safety specialist jobs will have had five to seven years of experience in the pharmaceutical industry. Extraordinary accomplishment on the job compensates for a lack of formal education (within limits). Most employers will look for at least two or three years of experience in some aspect of drug safety.


Work for contract research organizations is also highly relevant to work as a drug safety specialist. The ability to interact with contract research teams is also extremely useful on the job as a drug safety specialist.

Also, any on the job experience working directly with pharmacovigilance with the FDA, or dealing directly with the FDA, is also favorably regarded by job recruiters.


What Can You Do to Make Your Application Stand Out from the Crowd?


If you want a job as a drug safety specialist, make sure you are fluent in the technical terminology of the field. You should be comfortable with the acronyms commonly used in office communications, as well as the preferred terminology of reports to the FDA and other regulatory agencies.


Drug safety specialists need to be comfortable working in a highly regulated environment. They display the patience needed to deal with government bureaucracies, and they have the emotional intelligence to keep marketers, administrators, and government representatives in their emotional comfort zones. Team building skills can make a critical difference in choosing the right applicant for the drug safety specialist job.


Hiring officers value demonstrated time management skills, and they look for candidates who have led teams with empathy, building trust.


In addition to the people skills drug safety specialists need, hiring officers look for critical thinking skills. They insist on strong verbal communication skills, both writing and speaking.


Not sure that you have all the qualifications for a drug safety specialist job? Read the job opening announcement carefully. Determine which qualifications are "must have" and which qualifications are "nice to have." If you have all the "nice to have" qualities, you may still get an interview and even a job offer, with a plan to bring your skills up to speed within an agreed-on time period.


Fladger Associates matches great job candidates to great jobs. Visit our site to read about current job opportunities, and then contact us at 302-836-3100.


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