Sepracor, Inc Work Values

Daily Duties at Sepracor, Inc:

• Conduct, track, and document due diligence with reporters in the form of emails, phone calls, and/or letters in order to collect adequate clinical information. • Provide presentations and conduct training at Investigator Meeting and CRA training to facilitate clinical study start activities. • Complete accurate data entry into Oracle AERS safety database per department established working practice instructions, conventions, and processes. • Determine appropriate regulatory reporting requirements in accordance with global regulations and guidelines (FDA regulations, ICH guidelines, etc). • Determine regulatory reporting requirements based on individual case assessments of seriousness, causality, and expectedness/listedness in accordance with regulatory guidelines and product labeling. • Accurately select event terms using clinical judgment, determine seriousness, and assess expectedness/listedness based on labeling documents. • Maintain accurate and thorough documentation in order to ensure good audit practice in compliance with GCP, GMP, ICH, Federal US, and any pertinent local regulations. • Conduct quality reviews of non-serious cases in order to ensure quality and consistency of information. • Ensure compliance with regulatory timelines for individual expedited case reports submissions and timely delivery of information for aggregate reports and other regulatory documents as requested. • Complete timely diligence, review, and processing of adverse event reports as requested in order to fulfill all regulatory reporting obligations.

What they like about Sepracor, Inc:

You give high priority to hiring firms with prestige. Market reputation and prestige of a firm may be determined through on-line research, and conversations with individuals working in your target industry. Note that firms "in the public eye" receive a great deal more critical publicity and attention than those operating with more anonymity. So as you assess your employment opportunities, be sure to seek out the positive aspects of the firm's reputation in addition to noting negative publicity the company may have received.

Tags

drug safety, pharmacovigilance, data management, dietitian, Electronic data capture, Oracle

Skills

These are some of the questions we asked our climbers about their experiences with Sepracor, Inc: