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Job Runner

 
  • Category: Healthcare
  • Education: Bachelors Degree
  • Employment Length: fulltime
  • Pay / Salary: $45
  • Source: Business
  • Ad #: 11617
 
Via: kellyjobsmnetwork Apply / More Info
 
Full Details

Kelly Services is seeking a Safety Scientist for a contract position based in Blue Bell, PA.  This assignment is scheduled to start in January 2018 and will go through the end of April 2018.  There is potential for this assignment to extend or possibly convert to permanent based on budget and performance. Qualified candidates will have pharmacovigilance knowledge, be able to identify gaps in processes and have strong initiative.  This is a high-volume (approximately 15-20 cases per day both serious and non-serious), high productivity department so ability to work under pressure is a must.  

Job duties include:

• Assist with the preparation of adverse event reporting plans (AERPs) and other plans as required 

• Maintain a listing of all administrative changes and updates 

• Ensure all processes as described are operational 

• Alert Project Management when activities fall outside SOW 

• Process and evaluate AE reports according to the customer’s standard operating procedures (SOPs): write the narrative, perform seriousness rating and causality and expectedness assessment 

• Ensure the quality and accuracy of data used to support any regulatory document, including but not limited to: ICSRs, aggregate data, requested line listings 

• Assist in the reconciliation of clinical and safety databases 

• Contribute to the preparation and quality control of safety aggregate reports, responses to authorities, company core data sheets, signal detection and assessment reports 

• Perform literature review for identification of case reports and other relevant safety information 

• Liaise with both internal and external vendors (clients, patients and HCPs) 

• Review/Quality check (QC) of source documents, coding, data entry, report generation and distribution 

• Monitor compliance metrics and ensure appropriate documentation when deficient

• Assist in evaluation and validation of systems to support safety 

• Other duties as assigned by management

Requirements:

• Minimum of 2 years pharmacovigilance experience in case processing and narrative writing 

• Need to have prior safety data experience in Argus, ARISg or similar databases and QC of data entry

• A healthcare background in pharmacy, nursing or related area or experience in clinical trials or post-marketing experience

• Data migration experience a plus

• Minimum of a 40 hour work week with overtime highly possible, working either longer days or on Saturdays 

 

If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!

 

Perks of being a Kelly employee:

• Weekly electronic pay

• Access to more than 3,000 online training courses though Kelly Learning center

• Group rate insurance options available immediate upon hire*

• Service bonus plan and holiday pay*

• Online application system

• Never an applicant fee

 

*perks to be received upon meeting eligibility requirements

 

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume. If you have questions, the recruiter for this position can be reached via email at gail.robilliard@kellyservices.com.

 

 
Map: Blue Bell PA
 
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