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Job Title: Drug Safety Associate/Sr. Drug Safety Associate
Job Location: CT: Norwalk
Pay Rate: Open
Job Length: full time
Start Date: 2008-03-30
Company Name: The Cambridge Group Ltd.
Contact: Stephanie Oscar
Phone: E-mail or fax only
Fax: 203-226-3856
Description: Drug Safety Associate/Sr. Drug Safety Associate
The Drug Safety Associate will consult with the Drug Safety Physician and
will initiate critical follow up, identify potential product complaints,
and consult / collaborate with internal colleagues and external
departments. Additional responsibilities include: participate in
development and review of content for conventions, SOPs and WPDs; perform
single case review for medical content & accuracy as assigned; confirm
re****tability; consult source do***ents as needed; initiate additional
follow-up or queries; enter corrections to system as required; communicate
potential signals to Drug Safety Physician; assist with surveillance
activities including review of case series & frequency re****ts; provide
education, training, and feedback to DSP resources; represent Drug Safety
in internal and external meetings; and participate in recruiting and
coaching DSP resources. Qualifications include: an RN, BSN, Nurse
Practitioner, Pharmacist, Physician Assistant or related degree required,
or Associates degree in a relevant field with commensurate Drug Safety
experience; 3 - 5 years of experience in a pharmaceutical company or
clinical environment required; a minimum 2 years Drug Safety experience
required (Sr. Level: Minimum 5 years of experience in a pharmaceutical
company or clinical environment required. Minimum 3 years in Drug Safety);
the ability to apply clinical experience or DS experience in adverse event
*****sment; an advanced understanding of FDA and international
regulations; advanced skills with Argus and basic MS Office applications;
working knowledge of eDocs; basic understanding of RADocs, GRASP; a
working knowledge of scientific terms, medical terminology and MedDRA.
Please refer to Job code TP3970 when responding to this ad.
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