Drug Safety Associate – Rockville

Categories: PharmaceuticalKAI Research, Inc. is a growing health research firm providing research support services to government agencies, pharmaceutical companies, academic institutions, associations, and community-based organizations. We are currently looking for an Associate Drug Safety Monitor to provide backup support to the Drug Safety Monitors. The Associate assists in monitoring and evaluating the safety of investigational and marketed drugs for our pharmaceutical clients and provides medical consultation to our clients, study sites and internal departments. Responsibilities include assistance in investigating and evaluating case reports associated with the safety of investigational and marketed drugs, reviewing the published medical literature for reports of adverse events, coding of adverse drug experiences and other events using the MedDRA coding dictionary, preparing expedited and periodic safety reports for submission to the Food and Drug Administration (FDA), and assisting in the revision of pharmaceutical product labeling. Requirements:Qualified candidates will have a degree in Nursing or other allied healthcare field with 3 years clinical experience. Excellent writing skills are required. Knowledge of Federal Drug Administration (FDA) regulations related to drug safety and data management experience is a plus. The ability to build and maintain good working relationships with clients, patients and healthcare professionals is required. Working knowledge of word-processing and database software, preferred. KAI offers an excellent benefits package including 401k and transportation benefit and a rewarding work environment. AA/EEO Employer.

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Salary: mid 60s - mid 70s