RPS
Career Opportunity
Title: Drug Safety Associate
Reference
Number: 9363
Location: Massachusetts
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Processing of adverse drug experiences for both marketed and investigational drugs, ensuring compliance with regulatory requirements and established Standard Operating Procedures (SOPs). |
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Processing of adverse drug experiences for both marketed and investigational drugs, ensuring compliance with regulatory requirements and established Standard Operating Procedures (SOP's). |
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All responsibilities associated with post-marketing adverse event reporting, including NDA and IND safety reports, Periodic Reporting and other tasks as assigned with minimal supervision. |
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A degree with clinical experience relevant to healthcare is preferred (RN, Pharmacist) |
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A minimum of 1-3 years pharmaceutical industry experience, preferably in drug surveillance or medical information is preferred; other relevant experience will be considered, e.g. clinical pharmacy, clinical research, nursing/clinical healthcare, drug development, clinical data entry/data management. |
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Good organizational skills combined with an ability to follow projects to completion while adhering to regulatory and legal requirements. |
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A knowledge of database management, computer database entry and other related applications and pharmaceutical industry documentation if desirable. |
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Excellent oral and written communication skills required. |
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Familiarity with medical terminology and documentation. |