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Reference Number:
10-08039
Job Description:
Assume primary responsibility to collect details of adverse events received by phone or mail for ethicals and biologics and perform initial assessment according to local procedures and in accordance with company global drug safety procedures. Create initial reports by directly entering information into Drug Safety databases, amend reports and enter follow-up information as acquired, and prepare report for FDA submission. Maintain continuous knowledge expertise in local and global requirements for safety reporting. Coordinate submission of technical complaints to the Quality Assurance dept and the matching of technical complaints that also involve adverse events. Assume primary role in conducting regularly scheduled and as needed educational sessions on adverse event reporting to company representatives in clinical communications, scientific relations, sales/marketing, and other internal customers.
Experience Level:
5+ Years
Requirements:
Must have BS in health science field, Registered Nurse (RN), Pharm.D or equivalent with at least 5 years experience in the pharmaceutical industry. Five (5) years experience with adverse drug reporting in a clinical setting. In depth knowledge of medical terminology. Willing to assume a high level of responsibility in assuring proper reporting of adverse events within the timelines mandated by Global Drug Safety.
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