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Drug Safety Specialist |
Career OverviewA drug safety specialist is in charge of the reporting, collecting and sharing of the results and issues around adverse event reports both for currently marketed drugs as well as for those that are in the experimental stages of development.
An adverse event report is a negative response to the drug during a clinical trial. These reports are used to identify the counter indications and side effects of the various medications that are marketed and sold both over the counter and by prescription.
The drug safety specialist must be aware of the various safety issues and protocols for the administration of the different drugs as well as have a good understanding of the possible complications with combining different medications or treatments. The drug safety specialist is not responsible for establishing or developing protocols and procedures but they are required to closely follow all guidelines and information provided by the drug experience coordinator and other team members.
The drug safety specialist should have good communication and interpersonal skills as well as be able to work on various reports and projects at the same time. Organizational and time management skills are a must for effective and efficient reporting and documentation.
The drug safety specialist needs to be aware of all federal, state and industry regulations with regards to the testing of drugs and treatments. A drug safety specialist will require data management skills as well as be able to produce written documents that clearly classify, explain and record all aspects of adverse event reports in a logical and standardized fashion.
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Career RequirementsThere are diverse requirements for a drug safety specialist depending on the type of clinical trials that are being completed. Usually a healthcare professionals such as RN, BSN, MSN or equivalent, a Bachelors or Masters level in life sciences, medical sciences or biotechnology or equivalent, with experience working in clinical trials and with adverse testing reports are all acceptable credentials. Many companies also require experience working in clinical safety fields.
For drug safety specialist levels two and above a Masters or PharmD is usually required as well as over 5 years working in drug safety, adverse event reporting or clinical areas.
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Job OutlookThere are many job opportunities available for those interested in a career as a drug safety specialist. The increase in funding to all aspects of biotechnology and medicine has lead to an increase in long-term research and projects.
These projects all require extensive clinical trial and reporting, all that is within the scope of a drug safety specialist. In addition the drug safety specialist often helps in marketing information and is critical to the safety aspects of the drug and treatment.
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Career TrackThe drug safety specialist may decide to enter more specifically into the supervisory or management role as their level of seniority increases. For obvious reasons there is significant supervision of entry level drug safety specialists and constant monitoring and supervision is always required.
Level two and above drug safety specialists may become more involved in contract work, marketing or even management position in quality control and other aspects of the manufacturing aspect of the drug.
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CompensationAn entry level drug safety specialist with less than three years experience can earn between $48,000 and $55,000 per year. Those drug safety specialists with more than three years experience and either a Masters or PharmD education level earn between $85, 000 and $110,000 per year, depending on level of training, experience, and number of staff supervised.
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