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Safety Compliance Associate

Posted 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.
Job Description:
Participate in handling of SAE and AE reports. Assist with related activities to support regulatory and company requirements.
JOB RESPONSIBILITIES:
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
Requirements:
Health care professional degree preferred; a minimum of 2 years of drug safety or clinical development industry experience or equivalent.
Experience
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.
Apply online at:
Job Title Safety Compliance Associate
Post Details
Email job.postings(at)kenexa.com
Employer's Website sh.webhire.com
Category
Job Discipline Job Discipline -> Biotech
Job Classification Job Classification -> Other
Job Type Job Type -> Full-time
Location Tarrytown, NY 10591
Key Words Clerical functions associated with Operations,Clerical functions associated with Operations, SAE reconciliation familiarity with ARISg
Start Date 20-April-2011
Deadline