Purpose of the Job . The responsibilities of the Global Patient Safety (GPS) Regional Center (RC) Associate/Senior Associate/Associate Consultant (known as Associate) is for the management and oversight of adverse events. This includes the management of adverse events within the GPS Systems, required follow up activities, and ensuring timely expedited reporting. The role requires process and quality oversight and procedural and regulatory expertise. The RC Associate is expected to effectively represent Global Patient Safety through collaboration with internal and external GPS colleagues and business partners and be constantly striving for efficiencies while maintaining compliance. An associate's responsibilities can vary depending on the needs and focus of a particular team or the associate's primary role (e.g., Global Lead Associate, Literature Associate).
Management of Adverse Events. Apply clinical judgment, critical thinking, regulatory knowledge and a quality mindset to the management of adverse event data within our GPS Systems to ensure compliance, efficiency and data integrity.
AE Data Management. Responsible for the completeness and accuracy of data management within the GPS Systems, and other associated case management activities. These activities may include but are not limited to:
Management of adverse events arising from various sources including but not limited to literature, Patient Support Programs (PSPs), Clinical Trials
(CT), spontaneous, pregnancy, devices, Lilly Market Research (LMR), etc.
Ensure the following: appropriate serious outcome criteria for adverse events is selected, appropriate terms selected from source documents, listedness and relatedness is completed accurately, and cases are available as appropriate for Medical Review.
Complete or verify MedDRA coding
Identify concomitant medication and relevant medical history o Prepare serious adverse event forms for clinical trials and provide testing assistance for Inform studies. o Collaboratively work with teams regarding any electronic database collection and determine how to ensure integrity of the SAE data during the course of the clinical trial
Ensure appropriate Follow Up is obtained utilizing a customer experience mindset whether working with patients, HCPs, or investigators/site personnel.
Provide device expertise including: support device-related and CATool case management activities, resolve 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
Expedited Reporting. Review and analyze individual adverse event reports to establish need to report to local regulatory authorities, and submit as necessary, in accordance to local regulation and internal procedures. Responsible for the completeness and accuracy of submitted reports. o Comply with internal and external timelines for managing adverse event data entry, and expedited reporting processes as appropriate.
Global GPS Oversight and Support. Utilize clinical case management expertise to provide oversight to ensure that adverse event data is managed appropriately to internal standards and external regulations by Lilly, partners and vendors.
Case Quality and Data Oversight; Vendor Oversight
Apply GPS quality practices to the adverse events managed with GPS systems. o Participate in local, regional and global audits and inspections
Provide study oversight, which may include the following: maintenance of EPM and late phase clinical trials information, perform end of study related activities, and maintenance of RSI IB collaboration site
Procedural and Regulatory Expertise
Develop detailed knowledge of GPS standards regarding management of adverse event reports
Keep current on global PV regulations, changes and practices related to GPS. o Act as subject matter expert for the creation, revision, and maintenance of GPS standard operating procedures and training. Provide training as required. o Develop an understanding/expertise of pharmacovigilance regulations
Understand the roles of the EU qualified person (QP) and ensure support is provided to fulfill the QP legal responsibilities
Understand and proactively manage incoming work by prioritizing and collaborating with global colleagues.
Prioritize work to ensure internal and regulatory timelines are met.
Ensure schedule management and workflow oversight is provided to all CCM associated vendors.
Understand and apply GPS business practices
Collaboration with Internal Partners and External Customers. 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.
Global Support to PV Personnel/Business Units and Interaction Functions
Provide PV expertise to support Affiliates, and Business Units, Medical, and Call Centers in GPS related activities as necessary
Partner to provide CCM expertise and communicate with colleagues including but not limited to Surveillance, Medical, Pharmacoepidemiology, Data Management, Business Alliance, Corporate, Quality and Legal. o 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 representing CCM providing expertise on local or global projects to ensure CCM are consistently delivering innovation and improvements
Internal Number: 49117
About Eli Lilly & Company
Company Overview 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 39,000 employees worldwide 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.