Location: 100 % REMOTE / Indianapolis, IN, 46225, US
Duration: 12 Months
Description:
Responsibilities:
Handles adverse event reports from scientific literature by collecting,
reviewing, and entering global adverse events reports; routes applicable
literature on adverse event cases to the appropriate clinical safety
physician for review. Provides support to global personnel regarding
Global Product Safety policies, processes and procedures by updating
SOPs, training tools/programs as necessary. Ensures regulatory
compliance for expedited submission of case reports to regulatory
authorities. Collaborates with internal and external customers to
prepare quality periodic/annual safety summary reports; partners with
Global Product Safety physicians to maintain and communicate product
safety profile analyses to appropriate persons and groups (e. g. ,
regulatory agencies). Lilly is an EEO/Affirmative Action Employer and
does not discriminate on the basis of age, race, color, religion,
gender, sexual orientation, gender identity, gender expression, national
origin, protected veteran status, disability or any other legally
protected status. Being on a temporary contractor assignment at Lilly
means working in an innovative culture where you have the opportunity to
support the work of thousands of others around the globe dedicated to
improving the lives of others. Lilly discovers and brings life-changing
medicines to those who need them, improves the understanding and
management of disease, and gives back to communities through
philanthropy and volunteerism. Eli Lilly passionately promotes food
security and fosters the human-animal bond to enrich the lives of its
customers and the customers they serve as well. Our values: integrity,
excellence, respect for people. Greater than 90% of workers rate their
Lilly assignment as above average or excellent.
Comments/Special Instructions
Candidate does not need to reside in Indiana. Candidate must have some
(6m-1year) eCTD publishing experience at a minimum.
