Associate Safety Management
6 meses atrás
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.
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.
**Primary Responsibilities**:
**1. Technical Capabilities**
- 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.
- 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.
- Provides support for translation processes.
- Provides shared learnings/training related to areas of proficiency.
- Participates as a cross functional team member of study teams, as assigned.
- Completes data reconciliation activities.
- Support configuration of safety data collection modules for cross-functional platforms (e.g., INFORM, Veeva, GCP)
- Understand functioning of systems owned GPS, contributing with updates / enhancements and solution of workflow issues.
**2. Quality, Compliance and Operational Oversight**
- Provide oversight to ensure that adverse event data is managed appropriately to internal standards and external regulations.
- Conduct quality assessments defined in prevailing procedures (e.g., peer review of individual cases, aggregate review of cases in PhV queries) 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.
- Perform safety reporting within relevant processes and timelines (e.g., expedited and periodic)
- Oversee safety reporting schedules and maintain metrics for compliance reporting.
- Oversee external collaborators/vendors to support quality and timely processing of adverse events from clinical trial, literature and spontaneous sources.
- Perform timely monitoring of workflow and reporting parameters to ensure compliance with regulations and performance metrics.
- Review and action deletion request reviews
- Perform User acceptance testing in system environments.
- Contribute with configuration, enhancement, and maintenance of automated activities related to case intake, data entry, expedited reporting, and operational oversight.
- Participate with internal audits and inspections to ensure accurate information is provided as needed.
- Understand the roles of the EU qualified person (QP) and ensure support is provided to fulfill the QP legal responsibilities.
**3. External Collaboration**
- Support activities related to new acquisitions and business alliances (e.g., case exchange, data migration quality verifications, document review, etc.)
- Provide expertise in PV knowledge of individual case processes and requirements to other functions within GPS and Lilly to ensure efficiency in execution of responsibilities.
- Provide PV expertise to support Affiliates, and Business Units, Medical, and Call Centers in GPS related activities, as necessary.
- Partner to provide expertise and communicate with colleagues including but not limited to Surveillance, Medical, Pharmacoepidemiology, D
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