Safety ScientistExpress Scripts Holding Company - Philadelphia, PA
This position is primarily responsible for supporting all operational functions within the Safety Department including, but not limited to, client interface and deliverables, individual case safety report (ICSR) case processing; assisting with project start-up: process flows; assist with database configuration needs; training and contributing to the development and maintenance of departmental standards (SOPs) and guidelines.
Registered Nurse, Pharmacist, or other health care professional degree
Comprehensive knowledge of ICH and FDA Regulations and Guidelines both clinical and post marketing
Knowledge of vaccine and medical device reporting requirements, a plus
Proficient with computer programs (Safety database, Word, PowerPoint, Excel)
Knowledge of database management and use of coding dictionaries
Good communication, interpersonal interaction, project management and organizational skills are essential
Fluent in English, additional language fluency a plus, but not required
Ability to multitask with exceptional time management skills
Ensure time management and assess quality of work
Able to provide constructive feedback for performance improvement when appropriate.
Specific Job Duties:
Assist with the preparation of adverse event reporting plans (AERPs)
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 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.
Liaise with both internal and external vendors (clients, patients and HCPs)
Medical review 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.
6 days 21 hours ago
Express Scripts Holding Company
applySafety Scientist Express Scripts Holding Company - Philadelphia, PA, United States
Abbott Diabetes Care communicated a recall of certain FreeStyle® strips used in the FreeStyle® Blood Glucose Meter built into the OmniPod Personal Diabetes Manager (PDM). They have also recalled the FreeStyle Flash® Meter and FreeStyle® Classic meters. Both recalls are being issued because glucose level readings using these products may provide erroneously low results which if not recognized may pose significant risks to your health.
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