Safety Associate II

Safety Associate II needed for a 6-month renewable contract. This position receives and reviews adverse event reports, identifies additional required information and obtains follow up information working directly with drug safety units corporate-wide. He/she is responsible for assessing causality and must be able to understand the underlying path physiology of disease states and adverse events and recognize differential etiologies of adverse events. He/she is responsible for preparation of expedited and periodic regulatory safety submissions and authoring the safety sections of study reports and annual reports. He/she helps identify safety signals, provides safety data queries, data analysis and summaries, mentors coworkers and participates in strategic planning, workflow modifications, SOP updates, audits, clinical project teams and other interdepartmental teams as necessary.

Smith Hanley Consulting Group,a division of Smith Hanley, specializes in providing clinical trials staffing to national pharmaceutical companies offering long-term contract services of Statisticians, SAS Programmers, Data Managers, Clinical Research Associates and other clinical specialties. Our professional recruiters are recognized leaders in the industry by placing junior to senior candidates into rewarding positions within leading pharmaceutical companies throughout the United States. For more than twenty years, we have built extensive client relationships. We strive to help our candidates make decisions that are consistent with their professional values, priorities and goals as well as provide our clients with candidates that meet their employment needs.