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Scientific. Clinical. Software Engineering

Project Specialist, Aggregate Safety Reporting

Edison-New Brunswick Metro Area, NJ

Job Type: Scientific Job Number: JN -062020-26981 Region: Edison-New Brunswick Metro Area

Job Description


To manage, plan and document the schedule of activities for aggregate safety reports (ASRs) for development and marketed products; To identify resources for ASR preparation; To support the communication and actions pertaining to ASRs; Ensure structure and coordination of ASRs; Facilitate ASR reviews; Incorporate Quality throughout the ASR process.

Ideal candidate:

-Experience with project planning (MS Project) is desirable

-MUST HAVE EXCELLENT communication skills - verbal, written, listening. This includes but is not limited to excellent use of English grammar, spelling, punctuation, etc.

-MUST BE A logical / critical thinker

-Experience in pharmaceutical industry operations (eg clinical operations or drug safety operations) or a regulated atmosphere is preferred


-BA or BS in a relevant major (health science, business)

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