Randstad Scientist in Bridgewater, New Jersey
salary:$60.81 - $71.54 per hour
date posted:Tuesday, August 7, 2018
Job Title: PV Scientist
Assemble information, date stamp, image source documents, create paper and/or electronic folders, associate electronic/paper information to electronic/paper folder as appropriate.
Verify the presence of all information required to be a case (product, reporter, event, and patient), and request critical missing information for non-cases by expeditiously contacting the reporter.
Identify duplicates and non-cases.
Incorporate physician input, append case files and perform in-process quality review for case receipt.
Submit/provide MedWatch/CIOMS I/E2b reports as applicable.
Update the safety database with the submission date.
Generate and work with other team members to send a follow-up letter/queries to the appropriate reporter using the most expedient mechanism, forwarding to clinical sites where appropriate.
Identify database cases eligible for archiving.
Perform reconciliation with licensing partners and CROs to ensure compliance and accurate receipt of all adverse event information.
Complete special projects as required. Assist with the imaging of case information to ensure all documents are scanned and archived appropriately in compliance with internal standards and regulatory guidelines.
Adhere to CAPAs from the Quality, Training and Compliance (QTC) group.
Experience: 6 to 9 years.
Education & Qualifications
Medical, Dental, and Vision Insurance
401K Plan with Company Match
Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.