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.

Are you a dynamic leader with a strong track record in pharmacovigilance and safety reporting? Do you have the vision and expertise to drive strategic transformation and ensure regulatory excellence? If so, we invite you to apply for the role of Senior Director/Executive Director, Periodic Aggregate Reports Group Leader at Lilly.

This pivotal role offers the opportunity to provide strategic leadership for the design, development, and implementation of operating policies and procedures for Lilly’s end-to-end Periodic Aggregate Safety Reports (PASR) processes. You will spearhead the transformation of PASR science, defining and driving the strategic roadmap for process improvement, digital enablement, and operational excellence.

Key Responsibilities:

· Oversight of the Periodic Aggregate Safety Reports group, providing strategic leadership for Safety Science-related activities.

· Representing Periodic Aggregate Safety Reporting and Safety Science on cross-functional teams.

· Establishing and maintaining periodic aggregate reporting procedures, tools, and templates to meet regulatory requirements and Lilly standards.

· Ensuring compliance with current regulations through monitoring key Compliance and performance indicators and supporting team development.

· Allocating appropriate reporting resources for all Lilly products and supporting the EU Qualified Person for Pharmacovigilance (EU QPPV).

Qualifications:

Strong working knowledge and understanding of regulations, guidelines, and regulatory precedence.

Proven experience in leading and managing periodic aggregate safety reporting processes (e.g., PSUR/PBRER, DSUR, PADER).

Expertise in creating and distributing SOPs, tools, and templates related to periodic aggregate reporting.

Ability to provide strategic and scientific input for pharmacovigilance activities across the product lifecycle.

Excellent leadership, communication, and collaboration skills.

This role reports directly to the Associate Vice President, GPS Safety Science.

Join us at Lilly and be part of a team that is committed to making a significant impact on global health through proactive safety strategies and regulatory compliance.

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 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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