Associate Director / Director – Pharmacovigilance Scientist – Global Patient Safety Full-time

Associate Director / Director – Pharmacovigilance Scientist – Global Patient Safety

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.

Purpose:

The Global Patient Safety (GPS) organization is delivering scientific, medical, and pharmacovigilance expertise in support of Lilly's products in development as well as for marketed medicines and devices globally. The Pharmacovigilance Scientist demonstrates clinical and scientific expertise to lead signal detection and management, evaluation of safety data, benefit-risk assessment, responses to regulatory inquiries, and regulatory-required periodic reporting. In this role, you will apply effective prioritization, critical thinking, and judgment-based decision making to implement these key results in compliance with global regulations and internal processes.

Primary Responsibilities:

Signal Detection and Signal Management

• Lead the proactive and systematic detection and validation of safety signals arising from multiple internal and external data sources, including spontaneous adverse event reports, clinical trial data, literature, regulatory databases (e.g., FAERS, VigiBase), and other sources
• Develop and implement product-specific safety surveillance plans in collaboration with GPS Medical physicians/scientists and cross-functional partners
• Apply epidemiologic principles and statistical methods using existing technology-assisted tools to identify potential safety signals from aggregate data and individual case reports
• Conduct signal validation activities, including case series analysis, case definition development, literature reviews, and assessment of medical plausibility to determine if signals warrant further investigation
• Prioritize identified signals for systematic review and analysis based on frequency, seriousness, and potential impact on the benefit-risk profile
• Develop strategy and author signal evaluation reports and safety topic assessments, in collaboration with GPS Medical and medical writing colleagues providing clear recommendations for risk mitigation strategies

Safety Data Evaluation and Analysis

• Define data acquisition strategy, methodology, and approach for comprehensive safety evaluations across the product lifecycle in collaboration with GPS Medical
• Perform in-depth analysis of safety data from clinical development programs and post-marketing surveillance to assess safety risks and identify trends demonstrating the ability to understand and communicate intricate scientific issues and strategy
• Collaborate with GPS Medical physicians, scientists, pharmacoepidemiologists, and biostatisticians to ensure thorough evaluation and aggregate analysis of safety data
• Lead and facilitate safety team meetings for assigned products
• Communicate relevant safety information to core team, business partners, and key interested parties in a well timed and effective manner

Benefit-Risk Management

• Support the development and maintenance of benefit-risk assessments throughout the product lifecycle, from clinical development through post-marketing
• Contribute to the authoring of Risk Management Plans (RMPs) including risk minimization strategies and pharmacovigilance plans
• Provide strategic input to safety communications in the form of labeling, medical information responses, and healthcare professional communications in collaboration with regulatory, medical, and legal teams to ensure accurate reflection of the safety profile
• Contribute to the creation and maintenance of Reference Safety Information (RSI) and Core Safety Information
• Support the preparation of safety-related sections for clinical documents including protocols, Investigator Brochures, informed consent/assent forms, and clinical study reports

Periodic Aggregate Safety Reporting and Regulatory Submissions

• Analyze safety data and contribute to authoring of relevant safety sections of global regulatory inquiries and periodic safety reports in collaboration with medical writing including in collaboration with GPS Medical:
• Development Safety Update Reports (DSURs)
• Periodic Adverse Drug Experience Report (PADER) / Periodic Adverse Experience Report (PAER)
• Periodic Safety Update Reports (PSURs)
• Periodic Benefit-Risk Evaluation Reports (PBRERs)
• Support regulatory submission activities including INDs, NDAs/BLAs, and MAAs by authoring and reviewing safety-related sections of regulatory documents in collaboration with GPS Medical
• Respond to health authority safety queries and requests for information in collaboration with regulatory affairs and other partners in collaboration with GPS Medical
• Prepare safety data for regulatory meetings and advisory committees as needed

Therapeutic Area Leadership Responsibilities:

• Serve as the primary pharmacovigilance science contact and subject matter expert for all products within the assigned therapeutic area, providing strategic guidance on safety surveillance and risk management approaches
• Coordinate and harmonize pharmacovigilance activities across the therapeutic area portfolio to ensure consistent application of scientific principles, signal detection methodologies, and regulatory strategies
• Lead cross-product safety assessments to identify class effects, shared safety concerns, or therapeutic area-specific safety patterns that may impact multiple compounds
• Facilitate knowledge sharing and guidelines across product teams within the therapeutic area, promoting scientific excellence and operational efficiency
• Provide strategic input to therapeutic area development strategies and portfolio decisions based on evolving safety knowledge and benefit-risk considerations
• Serve as the primary liaison between GPS and therapeutic area Business Unit Medical teams, Clinical Development, and Regulatory Affairs leadership
• Lead therapeutic area-specific safety forums and working groups, bringing together partners across products to address common safety challenges and regulatory requirements
• Mentor and provide technical guidance to pharmacovigilance scientists supporting products within the therapeutic area
• Be responsible for the external safety landscape for the therapeutic area, including competitor products, emerging scientific literature, and evolving regulatory expectations
• Represent GPS in therapeutic area leadership meetings and design planning sessions

Leadership and Continuous Improvement

• Serve as subject matter authority on pharmacovigilance and safety surveillance, representing GPS on cross-functional clinical and commercial teams
• Accelerate the advancement of and contribute to the development, coaching, and mentoring of peers and less experienced employees
• Identify and develop innovative approaches to organizational effectiveness, productivity, and safety science
• Contribute to the evaluation and piloting of novel, technology-assisted tools and methodologies for safety data analysis, including artificial intelligence and machine learning applications
• Adhere to requirements in quality system documents and process improvement initiatives to ensure compliance with global regulations including ICH, FDA, EMA, and other regulatory authority guidelines
• Support health authority inspections and audits as a pharmacovigilance subject matter expert
• 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:

• BS degree in a health-related or scientific field with 7 years of experience in pharmaceutical industry, or clinical trial experience or experience in drug discovery/development, e.g. epidemiology, toxicology, pharmacovigilance, regulatory affairs.

Other Information/Additional Preferences:

• (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.
• Clinical knowledge of various disease states, drug effects, human physiology and pharmacology
• Experience within Global Patient Safety or demonstrated understanding of Pharmacovigilance is preferred
• Ability to manage multiple results 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 for further assistance.

Lilly is proud to be