A drug safety associate tracks and investigates safety issues and adverse drug reactions during clinical trials or after a drug has been introduced on the market. They manage case reports, analyze data, maintain documentation, file timely reports, educate the media or public, and design and maintain drug safety management programs. A degree in pharmacy, nursing, or life sciences and at least one year of experience in a drug safety environment is required.
In pharmaceutical research and production, a drug safety associate is responsible for tracking and investigating safety issues and adverse drug reactions. Depending on the assigned role, this could be during clinical trials or after the drug has been introduced on the market. Within the scope of the role, he will manage case reports, organize and analyze associated data, and maintain documentation of all investigations and their findings. At times, working with regulatory and medical authorities, the drug safety associate is responsible for filing timely reports on associated cases in accordance with company procedures. The work may also involve educating the media or the public directly about the safety of a particular drug.
Using the company’s preferred data management system, the drug safety associate will record all case reports received. Thereafter, he or she will also file these reports with the necessary regulatory authorities and other entities that may have an interest in the case. This process includes verifying contact information for all participants on cases, as well as verifying the accuracy of archived reports. During clinical trials, he or she generally follows the same procedures, but externally may contact investors rather than regulatory agencies. In addition, with clinical trials, he or she will also monitor adherence to contracts and investigate the trial process to ensure safety and proper procedures.
Often, the work will require extensive investigative research efforts. This research will include reading peer-reviewed literature, analyzing medical and laboratory results, or performing these tests directly. With clinical trials, this may also involve reviewing protocols. Other tasks will include interpreting analyzed results and providing medical or scientific advice to medical authorities in the field or to laboratory researchers. Completion of an investigation will also require written reports documenting all actions taken during the investigation and its final conclusion.
In addition to conducting investigations, the drug safety associate is also responsible for designing, implementing, and maintaining drug safety management programs. Establishing security guidelines, as well as ensuring proper security databases and the quality of data entry into those databases, is only part of the job. During the investigation process, he or she is responsible for presenting the security program when necessary. Safety training falls into this same management category with the drug safety associate providing training on the same use of company drugs both internally and externally. Becoming a drug safety associate will therefore require a degree in pharmacy, nursing or life sciences, with at least one year of experience in a drug safety environment.
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