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In pharmaceutical research and production, a drug safety associate is responsible for tracking and investigating safety issues and adverse reactions of drugs. Depending on the assigned role, this may occur during clinical trials or after the drug is introduced to the market. Within the scope of the role, he or she will manage case reports, organize and analyze the associated data, and maintain documentation of all investigations and their findings. Sometimes working with regulatory and medical authorities, the drug safety associate is responsible for filings timely reports on associated cases in accordance with company procedures. The job may also entail educating the media or public directly about the safety of a particular drug.
Using the company’s preferred data management system, the drug safety associate will log all incoming case reports. Thereafter, he or she will also file those reports with required regulatory authorities and other entities that may have a stake in the case. This process includes verifying contact information of all participants in the cases as well as verifying accuracy on filed reports. During clinical trials, he or she will usually follow the same procedures, but externally may file with investors rather than regulatory agencies. Additionally, 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 job will require extensive investigative research efforts. Such research will include reading peer-reviewed literature, analyzing medical and lab results, or conducting those tests directly. With clinical trials, this may also involve analyzing protocols. Other tasks will include interpreting the results analyzed and providing medical or scientific advice to medical authorities in the field or to researchers in the lab. Wrapping up an investigation will also require written reports documenting all actions taken during the investigation and its final conclusion.
Aside from conducting investigations, the drug safety associate is also responsible for designing, implementing and maintaining the drug safety management programs. Establishing safety guidelines as well as ensuring proper safety databases and the quality of data input into those databases is only part of the job. During the investigative process as well he or she is responsible for presenting the safety program when required. Safety training falls under this same category of management with the drug safety associate providing training regarding the same use of the company’s 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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