OSI Pharmaceuticals is committed to shaping medicines and changing lives by discovering, developing and commercializing high-quality and novel pharmaceutical products that extend life or improve the quality of life for patients with cancer, diabetes, and obesity.
OSI is consolidating its offices to Ardsley, New York in 2010.
This position may initially work at the Boulder, Colorado site for training; but will be required to move to NY when the timing is appropriate.
Primary Responsibilities: Our Drug Safety department currently has an opening for a Drug Safety Associate I/II.
This individual works works fairly independently in receiving and reviewing serious adverse event (SAE) reports for completeness, performing initial triage and data entry into the Safety database.
Obtains follow-up information as necessary.
Recognizes potential or impending problems and implements solutions.
Performs routine data queries and generates routine and ad hoc reports.
Creates and maintains SAE source documentation and files.
Prepares SAE documents for submission to regulatory authorities.
Receives and reviews serious adverse event (SAE) reports from clinical trials and adverse event reports from spontaneous sources and identifies discrepancies Handles database entry, event and disease coding and determination of listedness and causality as necessary for AE reports.
Responsible for follow-up and internal QA Performs queries and generates ad hoc reports from the database Prepares documents for submission to regulatory authorities in established timelines in order to meet regulatory reporting requirements.
Maintains SAE source documentation and maintains department safety files Participates in development of department procedures and policies.
Education/Experience Requirements: Bachelors Degree in a healthcare discipline typically required; however, strong drug safety experience (3+ years) with a Bachelors degree in a life science may be considered.
1 to 2 years of drug safety experience preferred.
Knowledge of US and European regulatory requirements and ICH guidelines.
Good working usage of MS Word, Excel, and PowerPoint preferred.
Strong attention to detail required.
To apply for this position please submit your resume to: http://careers.osip.com Reference Job # OSI 1003To learn more about OSI Pharmaceuticals, Inc. visit our website http://www.osip.com
Drug Safety Associate I/II Job in Ardsley 10502, New York US