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- Tasks: Lead the Periodic Aggregate Safety Reports group and ensure regulatory compliance.
- Company: Lilly is a global healthcare leader dedicated to improving lives through innovative medicines.
- Benefits: Enjoy a supportive work culture with opportunities for professional growth and community engagement.
- Why this job: Make a real impact on global health while driving strategic transformation in safety reporting.
- Qualifications: Strong knowledge of regulations and proven experience in safety reporting processes required.
- Other info: Lilly values diversity and offers equal opportunities for all applicants.
The predicted salary is between 72000 - 108000 £ per year.
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 this pivotal role that 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).
- 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 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.
Senior Director/Executive Director, Global Patient Safety Global Periodic Aggregate Safety Repo[...] employer: Eli Lilly and Company
Contact Detail:
Eli Lilly and Company Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Director/Executive Director, Global Patient Safety Global Periodic Aggregate Safety Repo[...]
✨Tip Number 1
Familiarise yourself with the latest regulations and guidelines in pharmacovigilance. Understanding the current landscape will not only help you in interviews but also demonstrate your commitment to compliance and excellence in safety reporting.
✨Tip Number 2
Network with professionals in the field of patient safety and pharmacovigilance. Attend industry conferences or webinars to connect with key players, as personal recommendations can significantly boost your chances of landing the role.
✨Tip Number 3
Prepare to discuss your leadership experiences in detail. Be ready to share specific examples of how you've driven strategic transformations or improved processes in previous roles, as this will be crucial for a senior position.
✨Tip Number 4
Research Lilly’s recent initiatives and contributions to global health. Being knowledgeable about their projects and values will allow you to align your answers during interviews, showcasing that you're a great fit for their mission.
We think you need these skills to ace Senior Director/Executive Director, Global Patient Safety Global Periodic Aggregate Safety Repo[...]
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the Senior Director/Executive Director position at Lilly. Tailor your application to highlight your relevant experience in pharmacovigilance and safety reporting.
Craft a Compelling CV: Your CV should clearly outline your leadership experience, particularly in managing periodic aggregate safety reporting processes. Use specific examples to demonstrate your expertise in creating SOPs and tools related to safety reporting.
Write a Strong Cover Letter: In your cover letter, express your passion for making a difference in global health and how your vision aligns with Lilly's mission. Highlight your strategic leadership skills and your ability to drive process improvements in safety reporting.
Proofread and Edit: Before submitting your application, thoroughly proofread your documents for any grammatical or typographical errors. A polished application reflects your attention to detail and professionalism, which are crucial for this role.
How to prepare for a job interview at Eli Lilly and Company
✨Understand the Role and Responsibilities
Before the interview, make sure you thoroughly understand the key responsibilities of the Senior Director/Executive Director role. Familiarise yourself with periodic aggregate safety reporting processes and how they align with regulatory requirements. This will help you articulate your relevant experience effectively.
✨Showcase Your Leadership Skills
As a dynamic leader, it's crucial to demonstrate your leadership capabilities during the interview. Prepare examples of how you've successfully led teams in pharmacovigilance and safety reporting, focusing on strategic transformation and operational excellence.
✨Prepare for Regulatory Questions
Given the importance of compliance in this role, be ready to discuss your knowledge of regulations and guidelines related to safety reporting. Highlight your experience in ensuring compliance and how you've monitored performance indicators in previous roles.
✨Emphasise Collaboration and Communication
This position requires strong collaboration across cross-functional teams. Be prepared to share examples of how you've effectively communicated and worked with diverse teams to achieve common goals, particularly in the context of safety science and reporting.
