Responsible for performing pharmacovigilance activities and maintaining compliance to corporate and departmental goals and worldwide regulatory timelines for OSI products. The Safety Associate works fairly independently in receiving and reviewing serious adverse event (SAE) reports for completeness, performing initial triage, data entry into the Safety database and quality review of data. Obtains follow-up information as necessary. Performs routine data queries and generates routine and adhoc reports. Creates and maintains SAE source documentation and files. The Safety Associate is responsible for preparation of expedited and periodic regulatory safety submissions and authoring the safety sections of study reports and annual reports. The Safety Associate helps identify safety signals, provides safety data queries and summaries and participates in workflow modifications, SOP updates, clinical project teams and other interdepartmental teams as necessary.
Bachelors degree preferably in a healthcare discipline and two or more years experience in a healthcare environment or the pharmaceutical industry Preferably in safety surveillance or related area. Must be proficient with MS Word, Excel, and PowerPoint
...an Equal Opportunity Employer:Minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity Paint Helper (Beaver Dam) US-WI-Beaver Dam Job ID: 2026-5000# of Openings: 2 Category: Manufacturing Metalcraft of Mayville (...
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...Private Duty CNA - Home Care page is loaded## Private Duty CNA - Home Carelocations: Brandon, FLtime type: Part timeposted on: Posted Todayjob requisition id: PRIVA014869**Certified Nursing Assistant (CNA) - Home Care**Empath Personal Care, a part of Empath Health, is...
...productionRegulated laboratory environmentsEducation/Experience:Education/Experience: Bachelors or Masters02 years of relevant laboratory or biotechnology-industry experience.Mammalian and/or CHO cell culture experience preferred.Experience with multi-omics, antibody production, or...