Drug Safety Scientist
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POST DATE 9/16/2016
END DATE 10/17/2016
United BioSource Corporation (UBC)
JOB DESCRIPTIONDrug Safety Scientist
Philadelphia (Blue Bell), PA OR Overland Park, KS
Advance your career with the company that makes it easier for people to choose better health.
Express Scripts is a leading healthcare company serving tens of millions of consumers. We are looking for individuals who are passionate, creative and committed to creating systems and service solutions that promote better health outcomes.
Join the company that Fortune magazine ranked as one of the 'Most Admired Companies' in the pharmacy category. Then, use your intelligence, creativity, integrity and hard work to help us enhance our products and services.
United BioSource Corporation (UBC) is the leading provider of integrated development and commercial support solutions that deliver evidence of safe use, while optimizing access to mediation and care.
This position is primarily responsible for supporting all operational functions within the Pharmacovigilance Department including, but not limited to, client interface and deliverables, individual case safety report (ICSR) case processing and reporting; assisting with project start-up: process flows; assist with database configuration needs; support preparation and quality control of safety aggregate reports; training, mentoring and contributing to the development and maintenance of departmental standards (SOPs) and guidelines.
Assist with the preparation of adverse event reporting plans (AERPs) and other plans as required
Review project specific proposals, pricing and protocols to ensure consistency within the AERP maintain a listing of all administrative changes and updates
Ensure all processes as described are operational
Alert Project Management when activities fall outside SOW
Participate in change order generation
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
Actively engage in gap analysis for SOPs and guidance documents
Preparation of training materials specific to safety, participate and/or lead training sessions
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
Perform literature review for identification of case reports and other relevant safety information
Collaborate with Senior Management to update or design project process improvements
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