Global Periodic Aggregate Safety Reports Scientist Full-time

Global Periodic Aggregate Safety Reports Scientist

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.

Location: Bracknell, UK (3/2 hybrid)

Reports to: Global Periodic Aggregate Safety Reports Group Leader

About Lilly:

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.

Role Overview:

As a Global Periodic Aggregate Safety Reports Scientist (Associate / Senior Associate / Manager / Senior Manager), your purpose is to ensure effective and accurate interpretation of global periodic reporting requirements. You will partner in the development of processes that reflect global regulatory trends and guidelines, aiming to represent best practices in the industry.

In this role, you will report to the Sr. Director/Executive Director, Global Periodic Aggregate Safety Reports Group Leader.

Main Responsibilities Include:

• Prepare, maintain, and communicate the Periodic Reporting Schedule to key stakeholders.
• Distribute PASRs to stakeholders, including safety affiliates and alliance partners.
• Prepare and submit DSURs and PBRERs/PSURs to the EMA within required timelines.
• Coordinate PADER/PAER waiver letters with GRA-NA and manage associated documentation.
• Maintain access to periodic reporting tools and generate submission and quality metrics.

Technical Expertise:

• Monitor deliverables and track regulatory changes (ICH E2C(R2), EU regulations, FDA guidance) to ensure global compliance.
• Act as subject matter expert on SOPs, tools, and resources related to periodic reporting.
• Mentor and train cross-functional team members on periodic reporting requirements and processes.
• Collaborate across departments to collect, validate, and quality-check data for periodic reports.
• Identify risks and resolve workflow issues, recommending process improvements.
• Partner with Pharmacovigilance Surveillance, Signal Management, Quality, Legal, and other stakeholders on system development and process design.
• Support safety inspections and audits by preparing documentation and coordinating responses.

Quality and Compliance:

• Deliver expected outcomes with minimal supervision.
• Support the EU QPPV in fulfilling legal responsibilities.
• Adhere to quality system documents, SOPs, and training requirements to ensure regulatory compliance.
• Collaborate on the creation and revision of processes and support regulatory inspections and internal audits.

Essential Requirements:

• Bachelor's degree (or equivalent) in a healthcare, scientific, or business discipline
• Understanding of pharmacovigilance regulations and guidelines applicable to periodic safety reporting (ICH E2C(R2), ICH E2F, EU GVP Module VII, FDA periodic reporting requirements)
• Experience in preparation, review, or submission of periodic safety reports (PBRERs/PSURs, DSURs) within a pharmaceutical or CRO environment
• Basic competence with medical and therapeutic terminology
• Excellent attention to detail and ability to manage multiple concurrent deadlines
• Ability to work independently with guidance from documented procedures

You'll Succeed in This Role If:

You're a strong communicator who's comfortable working with diverse cross-functional teams and stakeholders at all levels. You take a proactive approach to problem-solving, spotting workflow issues early and finding practical solutions. You're naturally collaborative, able to build relationships across different functions, and you're happy to mentor and support colleagues, particularly when it comes to periodic reporting processes.

Embracing Diversity:

Embracing diversity is at the core of our long-held value of respect for people. It is the lens through which we understand and respond to the unique needs of the millions of individuals who depend on our medicines. For us, embracing diversity means understanding, respecting, and valuing differences, including but not limited to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. The greatest measure of our diversity efforts is our ability to attract and retain exceptional employees who feel comfortable in a culture that supports them being themselves.