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.
Job title: Global Periodic Aggregate Safety Reports Scientist
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:
Periodic Report Expertise
- Contribute to the end-to-end periodic reporting process for a large global portfolio, supporting the scheduling, authoring, quality review, submission, and distribution of all global Periodic Aggregate Safety Reports.
- Provide SME guidance to report writers and cross functional contributors on periodic reporting requirements, regulatory expectations, and report preparation best practices
- Maintain the Global Periodic Reporting Schedule, ensuring all amendments are accurately reflected and communicated to key stakeholders.
- Support the preparation and submission of periodic reports to the EMA within required timelines.
- Support the generation of submission and quality metrics.
Technical Expertise
- Apply working knowledge of ICH E2C(R2), EU GVP Module VII, FDA guidance (21 CFR 314.80), and the EU Clinical Trials Regulation to support deliverables meeting applicable standards.
- Monitor regulatory changes across key markets and support the translation of these into updated procedures and ways of working.
- Support the mentoring and training of team members and cross-functional partners on periodic reporting requirements and processes.
- Collaborate across departments to ensure, validated, and quality-check and submission ready data for periodic reports.
- Identify and escalate risks across periodic reporting activities, supporting the implementation of mitigation strategies to protect compliance and timelines.
- Recommend process enhancements and partner with Pharmacovigilance Surveillance, Signal Management, Quality, Legal, and other stakeholders on process design and system development.
- Provide periodic reporting requirements and user perspective to support the development and enhancement of pharmacovigilance systems and tools.
- Contribute to continuous improvement of periodic reporting processes, systems, and metrics.
- Serve as a subject matter expert on periodic reporting SOPs, tools, systems, and cross-functional data requirements.
Quality and Compliance
- Support inspection and audit readiness by maintaining accurate documentation, executing quality control procedures, and contributing to responses for regulatory inspections and internal audits.
- Deliver quality work adhering to all applicable SOPs, quality system documents, and training requirements.
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.
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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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