Eli Lilly

Associate Director/Director, Pharmacovigilance Scientist Team Leader, Global Patient Safety

Cork, Ireland · full_time

About the job

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work - but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Purpose:

The Global Patient Safety (GPS) organization is responsible for delivering scientific, medical, and pharmacovigilance expertise in support of Lilly's products in development as well as for marketed medicines and devices globally. The Leader - Pharmacovigilance (PV) Scientist Team provides strategic leadership and operational oversight for a team of Pharmacovigilance Scientists, ensuring excellence in signal detection and management, safety data evaluation, benefit-risk assessment, regulatory compliance, and periodic reporting. In this role, you will combine advanced technical expertise with people leadership to drive team performance, foster professional development, and ensure the delivery of high-quality pharmacovigilance deliverables that comply with global regulations and support Lilly's mission of patient safety.

Primary Responsibilities:

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any role/position can change over time and can include additional responsibilities not specifically described in the job description. Consult with your supervisor regarding your actual job responsibilities and any related duties that might be required for the role/position.

Team Leadership and People Management

  • Provide direct supervision and leadership to a team of Pharmacovigilance Scientists, including workload management, performance evaluation, and career development
  • Provide coaching, feedback, and support for professional growth
  • Lead recruitment, onboarding, and training of new team members
  • Foster an inclusive team culture that promotes trust, respect, accountability, and psychological safety
  • Conduct performance reviews, set clear objectives, and develop individualized development plans for team members
  • Manage team resources and workload allocation to ensure timely delivery of pharmacovigilance deliverables
  • Address performance issues promptly and constructively, implementing corrective action plans when necessary
  • Serve as an advocate for team members, supporting their career progression and recognition within the organization

    • Strategic Oversight of Signal Detection and Signal Management

  • Ensure the team conducts proactive and systematic detection, validation, and evaluation of safety signals arising from multiple internal and external data sources
  • Provide guidance on the development and implementation of product-specific safety surveillance plans in collaboration with GPS Medical physicians, scientists, and cross-functional stakeholders
  • Serve as a point of escalation for complex pharmacovigilance activities and safety assessments
  • Ensure timely completion of signal evaluation reports and safety topic assessments with appropriate prioritization and risk mitigation recommendations
  • Perform PV scientist signal management responsibilities for products that are assigned

    • Safety Data Evaluation and Analysis

  • Ensure the team defines appropriate data acquisition strategies, methodologies, and approaches for comprehensive safety evaluations across the product lifecycle
  • Provide scientific guidance and serve as escalation point for complex safety data analysis questions
  • Enable and promoter collaboration between Pharmacovigilance Science team members and GPS Medical physicians, scientists, pharmacoepidemiologists, and clinical development partners.
  • Ensure team members effectively communicate relevant safety information to core teams, business partners, and key stakeholders in a timely manner
  • Ensure the team maintains high standards for understanding and communicating complex scientific issues and strategy
  • Perform PV scientist signal management responsibilities for products that are assigned

    • Risk Management

  • Ensure the development and maintenance of risk assessments throughout the product lifecycle, from clinical development through post-marketing, ensuring scientific rigor and strategic alignment
  • Provide leadership and coaching to ensure cross-functional collaborations with regulatory, medical, and legal teams to develop safety communications including labeling, medical information responses, and healthcare professional communications that accurately reflect the safety profile
  • Provide oversight and coaching for safety-related sections of clinical documents including protocols, Investigator Brochures, informed consent/assent forms, and clinical study reports

    • Periodic Aggregate Safety Reporting and Regulatory Submissions

  • Ensure timely and high-quality completion of periodic safety reports (DSURs, PADERs/PAERs, PSURs, PBRERs) by providing strategic direction and quality review
  • Oversee team responses to health authority safety queries and regulatory submissions
  • Ensure compliance with global pharmacovigilance regulations including ICH, FDA, EMA, and other regulatory authority guidelines
  • Serve as a subject matter expert during health authority inspections and audits Monitor and ensure adherence to quality system requirements and process improvement initiatives ensuring inspection readiness
  • Track and monitor team deliverable timelines and escalate risks to completion as appropriate

    • Organizational Leadership and Continuous Improvement

  • Identify opportunities to improve organizational effectiveness, productivity, and quality of safety science deliverables Lead or participate in departmental initiatives, process improvement projects, and organizational change management
  • Contribute to the development of departmental strategy, policies, and procedures Build and maintain strong collaborative relationships with internal stakeholders including Regulatory Affairs, Clinical Development, and Quality Represent GPS in enterprise-wide initiatives and cross-functional leadership forums
  • Foster knowledge sharing and best practice dissemination within and across teams Support organizational change initiatives and serve as a change champion for the team
  • Contribute to annual business planning and resource allocation decisions for the team
  • Ensure support is provided to enable the Qualified Person to fulfill all the Qualified Person legal responsibilities Demonstrate and apply pharmacovigilance knowledge, including understanding the role of the QPPV, to ensure compliance with local laws and regulations
  • Maintain compliance with Lilly Red Book and corporate policies, Lilly Research Laboratories and Global Patient Safety curriculum. Maintaining compliance with the Lilly Corporate Integrity Agreement.

    • Minimum Qualification Requirements:

  • Advanced medical related graduate degree, such as: pharmacy (PharmD), nursing with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner), PhD with 1-3 years' experience in related scientific field, e.g. pharmacology, physiology, microbiology or scientifically related field. OR
  • BS degree in a health-related or scientific field with 7-10 years of experience in pharmaceutical industry, directly related clinical trial experience or experience in areas relevant to drug discovery or development, e.g. epidemiology, toxicology, pharmacovigilance, regulatory affairs.

    • Additional Preferences:

  • Clinical knowledge of various disease states, drug effects, human physiology and pharmacology
  • Experience in the pharmaceutical industry and/or demonstrated understanding of pharmacovigilance
  • Experience in a supervisory role with demonstrated effective leadership
  • Strong knowledge of regulations and guidelines that apply to patient safety regulatory obligations
  • Demonstrated ability to manage multiple deliverables simultaneously

    • Lilly is an EEO/Affirmative Action Employer and 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.

    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](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.

    Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

    €78,750 - €115,500