Associate Director - Global Patient Safety - Global Periodic Aggregate Safety Reports Scientist

Company: Eli Lilly and Company
Location: Indianapolis
Posted on: July 3, 2025

Job Description:

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 the Global Periodic Aggregate Safety Reports Scientist is to ensure effective and accurate interpretation of global periodic reporting requirements. This involves partnering in the development of processes that reflect global regulatory trends and guidelines, aiming to represent best practices in the industry. Primary Responsibilities Global Periodic Aggregate Safety Report Technical Expertise Ensure periodic report deliverables meet global regulatory requirements by tracking and aligning them effectively. Serve as a subject matter expert of SOPs, required tools and resources related to periodic reporting. Provide centralized mentoring and training for safety and cross-functional team members working on periodic reports. Provide subject matter expertise and guidance to team members to ensure compliance and efficiency in report preparation. Stay updated with global regulatory requirements and ensure all reports adhere to these standards. Ensure periodic reports meet global regulatory requirements by interpreting and applying guidelines. Work closely with various departments to gather necessary data and insights for periodic reports. Implement quality control measures to ensure the accuracy and completeness of reports. Address any issues or discrepancies in the report preparation process and find solutions to improve workflow Partner in developing processes that reflect global regulatory trends and best practices. Analyze data to ensure accuracy and completeness in reports. Work closely with various departments to gather necessary data and insights for periodic reports. Oversee the preparation, review, and submission of periodic safety reports and other regulatory documents. Monitor and interpret global regulatory changes and trends to ensure compliance and update processes accordingly. Maintain effective communication with internal and external stakeholders, including regulatory authorities, to ensure timely and accurate reporting. Identify and assess potential risks related to periodic reporting and implement strategies to mitigate these risks. Drive continuous improvement initiatives to enhance the efficiency and quality of periodic reporting processes. Participate in safety inspections and audits, including support and coordination of required responses and the business approval of responses. Leverage periodic reporting expertise, knowledge of internal and external requirements, industry best practices and benchmarks, new capabilities, and advances in technology, including information flow, to influence operational strategy and design processes that meet overall signal management pharmacovigilance objectives. Engage in coaching and training others, as needed, to ensure the effective implementation and execution of periodic reporting processes in Lilly’s safety systems Responsible for providing PV surveillance and periodic reporting input when developing new and existing GPS systems, tools, technologies and strategies in support of signal management related business processes. Collaborate with Pharmacovigilance Surveillance, Signal Management Process Owner, functional leaders, subject matter experts (SMEs), Quality, and Legal to understand applicable compliance, business, and regulatory requirements to support system development and the design of efficient processes related to periodic reporting. 2. Enterprise Leadership Responsible for effective communication and influence with internal Lilly customers and external stakeholders. Identify and develop innovative approaches to continuously improve organizational effectiveness and productivity. Effectively function and communicate as part of inclusive cross functional teams (e.g. GPS, Research and Business Unit team members, other safety personnel) that foster trust, respect, and accountability. 3. Understand and Support of the EU QPPV Role Understanding the roles and responsibilities of the EU Qualified Person. Ensure support is provided to enable the Qualified Person to fulfill all the Qualified Person legal responsibilities. Minimum Qualification Requirements: Bachelor’s degree in healthcare, scientific field or business background. 5 years of experience in regulatory affairs, pharmacovigilance, or a related area. Other Information/Additional Preferences: Experience with global regulatory requirements and periodic reporting processes. Understanding of regulations and guidelines that apply to patient safety regulatory obligations Basic competence with medical and therapeutic terminology Effective communication skills to interact with diverse groups, teams and individuals Ability to work independently with guidance from documented procedures, with appropriate support. Ability to multi-task many projects at once in a fast-paced environment with tight deadlines. Excellent attention to detail 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 $111,000 - $162,800 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. WeAreLilly

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