Deputy European Union (EU) Qualified Person for Pharmacovigilance (m/f/d)

Employment Type: Full-time

Position Overview

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.

Responsibilities

• Deputise for the EU Qualified Person for Pharmacovigilance: Fulfill the legal and regulatory requirements for the EU Qualified Person for Pharmacovigilance (QPPV) role, as defined by current EU legislation and guidelines, in the absence of or as delegated by the EU QPPV.
• Ensure appropriate coordination and coverage with the QPPV, including timely provision of all necessary information to support the role.
• Maintain up-to-date awareness of EU regulatory developments; provide timely feedback to GPS leadership and guidance to the Medicines Quality Organisation as needed.
• Review and contribute expert input to EU regulatory submissions, PASS protocols, and actions related to emerging safety concerns, ensuring effective risk minimisation and compliance with timeliness, accuracy, and completeness of safety data submitted to Competent Authorities and EMA.
• Provide QPPV input to GPLC in the absence of or as delegated by the QPPV, and fulfill all other delegated QPPV responsibilities per Good Pharmacovigilance Practice (GVP) guidelines.
• Actively contribute to the GPS Leadership Team, SRC, GPLC, and other committees as appropriate; offer strategic and technical advice across global regulatory and medical functions.
• Serve as an independent expert on safety issues, maintaining strong links with Global Regulatory Affairs, and offering consultancy on safety-related content in EU submissions, CHMP responses, and product information documents.
• Provide external technical leadership through engagement in pharmacovigilance forums and integrate shared learning into the organization.
• Deliver training, coaching, and mentorship to safety surveillance scientists, Global Patient Safety physicians, clinical researchers, and other relevant medical and regulatory personnel.
• Support recruitment and succession planning by advising on candidates for managerial and physician roles, as requested.

What challenges await you?

• Deputise for the EU QPPV as required, fulfilling all legal and regulatory obligations in their absence and as delegated.
• Provide strategic and technical pharmacovigilance advice to Global Patient Safety (GPS) and other regulatory and medical functions within the Medicines Development Unit.
• Actively contribute to the GPS Leadership Team, Safety Review Committee (SRC), and other relevant committees.
• Demonstrate GPS expertise and leadership through training, coaching, and mentoring.
• Represent the EU QPPV on the Global Product Labelling Committee (GPLC) as needed.

Your Profile

If you can look back on the following successes in your career to date, you bring the best prerequisites with you:

• Medical degree with clinical experience, ideally with a global perspective and eligibility to work/reside in the EU/EEA.
• Minimum 5 years in pharmacovigilance, with solid understanding of epidemiology, drug safety regulations, and benefit-risk assessment methodologies.
• Proven clinical judgment, problem-solving, and decision-making skills, especially under pressure.
• Excellent communication, coaching, and influencing abilities across diverse stakeholders and seniority levels.
• Strong writing, presentation, and interpersonal skills; effective in team-based and independent work environments.
• Data-driven mindset with familiarity in quality systems and a commitment to continuous learning and shared knowledge.

Company Information

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.