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Drug Safety Scientist
KEY TASKS & RESPONSIBILITIES
Provide initial medical evaluation of adverse events on company investigational and marketed products by determining the seriousness, expectedness, and therefore reportability of adverse events in line with FDA and global regulatory guidelines.
Collect high quality medical follow-up information for serious cases.
Perform quality review of clinical trial cases and develop queries as appropriate.
Perform quality review of post-marketing serious adverse event reports as applicable.
Perform initial assessment of non-adverse events to evaluate validity of report and identify requisite follow up.
Log onto USDS phone line to receive incoming calls of potential adverse event reports and document information according to approved standards.
Determine reportability including assessment of labeling for clinical trial and post-marketing cases processed by Global Drug Safety and distributed to US Drug Safety for potential reporting.
Determine if adverse events should be reported to other manufacturers as required.
Coordinate development of periodic safety reports and contribute to the development of aggregate reports as requested by US Drug Safety Medicine.
Support Product Lead in signal detection activities as assigned.
Participate in the set-up and approval of local clinical trials by developing drug safety manuals and SAE reconciliation plans, and conducting CRF reviews, and collaborating with US Drug Safety Medicine and GDS for the development and execution of Clinical Development plan as needed.
Collaborate with GDS Staff to ensure a consistent global approach to safety by participating in meetings and implementing global standards within the department.
Work closely with Medical Directors and Associate Medical Directors to ensure alignment by providing operational expertise.
Represent USDS Operations with respect to the safety aspects of investigational and marketed products with external groups and on select cross-functional teams as appropriate.
Provide medical operations expertise and help develop relevant training content for the case processing group and external vendors.
Participate in internal and external training programs, meetings, and conferences to continually improve and build a knowledge base of product safety and risk management.
Perform Sample QA per USDS and EMD Serono guidelines in order to identify quality trends and implement preventative actions.
Obtain detailed knowledge of FDA and global safety regulations as applicable to assigned products and responsibilities.
Health care professional
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