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Safety Compliance AssociatePosted by: Regeneron
Posted date: Apr-20-2011
Location: Tarrytown, NY 10591
Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has evaluated therapeutic candidates in Phase 3 clinical trials for the potential treatment of gout, diseases of the eye (wet age-related macular degeneration and central retinal vein occlusion), and certain cancers. Additional therapeutic candidates are in earlier stage development programs in rheumatoid arthritis and other inflammatory conditions, pain, cholesterol reduction, allergic and immune conditions, and cancer.
Participate in handling of SAE and AE reports. Assist with related activities to support regulatory and company requirements.
· Participate in initial handling of SAE and AE reports.
· Assist with preparation and submission of reports and other documents required for health authorities
· Assist with departmental clerical functions associated with Operations.
· Participate in SAE reconciliation activities
· Typically reports to PV Operations Manager/Sr. Manager
· Health care professional degree preferred; a minimum of 2 years of drug safety or clinical development industry experience or equivalent.
· Experience with electronic databases; familiarity with ARISg safety database helpful.
· Advanced knowledge of PC required. Advanced proficiency in use of Microsoft Office suite, Adobe Acrobat, and electronic document management systems also required.
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