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Title: Drug Safety Associate
Job listing published: 6/14/08
Location: California
Department: Medical Regulatory Affairs
Contact: To apply for this position, please email your resume to Synteract Jobs.
Description
In this position, you will receive and analyze Serious Adverse Event (SAE) information for completeness, accuracy and regulatory reportability requirements; evaluate SAE case data with an emphasis on medical presentation, conduct discussions regarding specific patient case data with health care practitioners and Sponsors; determine regulatory reporting requirements based upon case data, product information, and FDA or ICH guidelines and regulations; prepare SAE Reports, including preparation of narrative summary; identify missing/discrepant data, write queries, address queries with site personnel, evaluate query responses, and resolve queries when complete. Additionally, you will maintain the SAE database and perform coding of adverse event terms and concomitant medications.
Qualified candidates will have a Bachelor's degree in nursing (B.S.N.), Registered Nurse (R.N.), or Doctor of Pharmacy and 3-5 years' relevant experience. Requires in-depth knowledge of medical terminology and of GCPs, ICH guidelines and FDA regulations with an emphasis on safety. Must posses a professional demeanor; demonstrate initiative, sense of urgency, ability to organize and prioritize, and keen attention to detail.
