Safety Surveillance Associate
Location: Bridgewater New Jersey
Description: Kelly Services is currently interviewing Safety Surveillance Associate right now, this job will be placed in New Jersey. Detailed specification about this job opportunity please read the description below. Kelly Services Clinical Research Team is seeking candidates for Safety Surveillance Associate. This is a twelve month contract position based in Bridgewater, NJ.
Details o! f Safety Surveillance Associate Responsibilities Include:
Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays
Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately
Review, rank, verify, process and document: event terms; case classifications validity, seriousness, expectedness/listedness/labelledness; special scenarios; product complaint information; reportability with due date; and accuracy and consistency
Based on assessment of cases, process accordingly
Review case criteria to determine the appropriate workflow for case processing
Write and edit the case narrative
Generate reports, ensuring adherence to regulatory compliance timelines
Determine and perform appropriate case follow-up, generating and requesting follow-up letters
Liaise with key partners, including Country Organizations, Clini! cal Development, License Partners, and other stakeholders rega! rding safety data collection and data reconciliation
Develop and maintain expertise and knowledge of: all assigned products within a therapeutic area; applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practices; data entry conventions; and search functions in the safety database
Consistently apply regulatory requirements and policies
Qualifications:
Degree in a science-related field, pharmacy, nursing, or equivalent (healthcare professional, RN, BSN or PharmD is preferred)
At least 1 year experience in drug safety or pharmacovigilance
Knowledgeable with ARGUS or ARISg safety database
Ability to achieve personal objectives while meeting departmental standards of performance
Ability to work under supervision in a matrix organization
Excellent oral and written communication skills
Fluency in spoken and written English; knowledge of additional language is an advantage
Perks of being a Kelly employee:
Weekly electronic pay
Access to more than 3,000 online training courses though Kelly Learning Center
PerkSpot Discount Program
Access2Wellness Program*
Group rate insurance options available immediate upon hire*
Service bonus plan and holiday pay*
Online application system
Never an applicant fee
If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!
Kelly Services, Inc. is an Equal Opportunity Employer
About Kelly Services ®
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions. Kelly ® offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis. Serving clients around the glo! be, Kelly provides employment to more than 560,000 employees annually. ! Revenue in 2012 was $5.5 billion. Visit kellyservices.com and download The Talent Project , a free iPad ® app by Kelly Services.
Our science specialty places professionals to a broad spectrum of industries, including biotechnology, chemical, clinical research, consumer products, biotechnology, consumer products, environmental, food sciences, pharmaceutical, and petrochemical fields.
Want more information? Visit kellyservices.com/science
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This job starts available on: Tue, 08 Oct 2013 01:54:28 GMT