Sr. Associate / Manager - Safety Management - RDMC Cork At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Purpose: The purpose of this role is operational execution of the activities related to the inputs, outputs and oversight of safety information and processes. This includes, but is not limited to data collection methods, safety reporting, and monitoring of performance indicators. The primary responsibilities in this role can vary depending on the business need and activities that are assigned by the supervisor.
Responsibilities: Apply clinical judgement, critical thinking, and regulatory knowledge to the management of adverse event data within GPS systems to ensure data integrity, consistency, and compliance.
Continuously expand knowledge of Lilly compounds/products (e.g., design of clinical trials, safety profile, regulatory commitments, indications, identified risks, main adverse reactions, risk minimization activities).
Continuously expand regulatory expertise on case collection and expedited reporting requirements dictated by major regulatory agencies (e.g., FDA, EMA, MHRA, PMDA).
Partner with other GPS areas and clinical functions (e.g., authoring of ERB or Investigator line listing, contributing to maintenance of EPM and late phase clinical trials information, performing trial closure activities).
Prepare serious adverse event forms for clinical trials and provide testing assistance for Inform studies.
Provide expertise related to data collection activities and configuration and determine how to ensure integrity through the data flow (e.g., Mosaic PV, Inform).
Provide device expertise including resolving issues related to CATool use to ensure appropriate linking of adverse event/product complaint information, complete follow-up/PC actions items to ensure relevant product information is updated in a timely fashion.
Participate as a cross-functional team member of study teams, as assigned.
Support configuration of safety data collection modules for cross-functional platforms (e.g., INFORM, Veeva, GCP).
Provide oversight to ensure that adverse event data is managed appropriately to internal standards and external regulations.
Conduct quality assessments defined in prevailing procedures and drive quality initiatives.
Responsible for leading and/or addressing quality control activities such as deviation identification, documentation, and Corrective Action Preventative Actions (CAPA) management related to the safety reporting process.
Review and analyze individual adverse event reports to establish need to report to regulatory authorities, and submit as necessary, in accordance with applicable regulations and internal procedures.
Act as subject matter expert for the creation, revision, and maintenance of procedures and resources, sharing expertise and providing training when required.
Perform safety reporting within relevant processes and timelines.
Oversee safety reporting schedules and maintain metrics for compliance reporting.
Perform timely monitoring of workflow and reporting parameters to ensure compliance with regulations and performance metrics.
Understand the roles of the EU qualified person (QP) and ensure support is provided to fulfill the QP legal responsibilities.
Basic Requirements: Bachelor's degree or equivalent experience. Healthcare degree, or study in the area of pharmaceutical/biological science preferred.
3 years+ experience in a similar position.
Critical thinking to solve problems, and make decisions autonomously, and as part of a team.
Fluency in English (write/read/speak).
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.
Lilly 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.
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