Associate/Sr. Associate/Manager - Safety Management

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: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

1. 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. ▪ 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 (e.g., MOSAIC, LSS), 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.

▪ 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.

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, 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.

▪ Maintain understanding of PV agreements for assigned products.

4. 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. 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 are 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.

▪ Ensure appropriate Follow Up is obtained utilizing a customer experience mindset whether working with patients, HCPs, or investigators/site personnel.

▪ Understand and proactively manage incoming work by prioritizing and collaborating with global colleagues.

▪ Prioritize work to ensure internal and regulatory timelines are met

Minimum Qualification Requirements:

▪ Bachelor’s degree with healthcare focus

OR

▪ Bachelor's degree AND 3+ years of Pharmacovigilance experience.

Other Information/Additional Preferences:

▪ 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.

▪ Demonstrated Pharmacovigilance experience

▪ Knowledge of global regulations with respect to adverse event reporting for both drugs and devices

▪ Knowledge of Argus safety database Veeva Products, Trackwise.

▪ Knowledge of product complaint database

▪ Anticipated travel of 10-15%

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. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$63,000 - $140,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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