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.
Organisation Overview: Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our 'Live Your BEST Life' wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!
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: Technical Capabilities: 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.Provide shared learnings/training related to areas of proficiency.Participate as a cross functional team member of study teams, as assigned.Complete 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 (e.g., MOSAIC, LSS), contributing with updates/enhancements and solution of workflow issues.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.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 (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.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, Data Management, Business Alliance, Corporate, Quality and Legal.Be a pro-active and consistent member of medical team meetings (PFT, DSST/SST, Inv. Training). Provide individual case knowledge to facilitate reconciliation and trial data completion.Provide expertise and authoring of ERB line listings or Investigator line listings with input from medical, toxicology, surveillance, and GPS medical.Provide expertise for the process flow for receiving serious adverse event data and changes or discoveries during studies.Liaison with Business Alliance for business partner, issues, review of safety agreements, process changes required to ensure business continuity.Be a pro-active member providing expertise on local or global projects to ensure Safety Management is consistently delivering innovation and improvements.Case Management activities (as assigned): Process adverse events and other safety information from various sources (e.g., Clinical Trials, Patient Support Programs, Lilly Market Research, literature, spontaneous reports, etc.).Assess individual reports identifying gaps of information and the need to conduct follow-up to clarify seriousness, expectedness, causality and achieve case completion.Comply with internal and external timelines for managing adverse event data entry.Lead/support literature search strategy updates and system issues/enhancements.Translate global / regional / local PhV regulatory requirements into expedited reporting rules and conduct Product License studies activities.Responsible for the completeness and accuracy of data management within the GPS Systems, and other associated case management activities.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.Ability to apply critical thinking and flexibility in the use of electronic systems and adapting new and changing systems.Basic computer skills (i.e., word processing, tables and graphics, spreadsheets, presentations, templates, databases, search engines).Ability to work effectively in a global team and apply understanding of diversity and inclusion.Fluency in English (write/read/speak).Additional preferences: Demonstrated PhV experience.Knowledge of global regulations with respect to adverse event reporting for both drugs and devices.Knowledge of Argus safety database.Knowledge of product complaint database.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 (https://careers.lilly.com/us/en/workplace-accommodation) 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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