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.
Organization Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Purpose:
The purpose of the Medical Device Safety Scientist Associate Director role is to leverage clinical and scientific expertise working across Lilly's device product portfolio to lead the completion of safety signal detection and clarification, preparation of device safety reviews, support for regulatory inquiries, input into device development and risk management activities, and the promotion and advancement of Global Patient Safety's capabilities in the field of device safety.
Primary Responsibilities:
Device Signal Management and Risk Management
- Effectively utilize available tools to identify, clarify and communicate device safety signals from multiple data sources
- Consult and coordinate with the Device Surveillance Senior/Executive Director and Device Safety Physician to facilitate appropriate signal management of device safety signals
- Consult with device teams in evaluating risk/benefit relationships and represent GPS throughout the development process
- Provide safety input and review for device related documents including clinical investigator brochures (IB), clinical trial protocols, and labelling (including affiliate requested revisions).
- Actively participate in device safety meetings
Device Safety Inquiries
- Define evaluation plan with partners device safety physician, device surveillance senior/executive director, team members, and internal business partners such as Pharmaceutical Delivery Systems (PDS) to appropriately assess and complete responses for device safety inquiries from both external and internal sources
Device Safety Reviews
- Review device safety data, complete the analysis, and author periodic device reports including trending summary reports and the annual PDS device safety summary reports
- Complete device safety sections for periodic reporting commitments involving device safety
- Meet timelines set for device safety reviews
Promote and Advance the Field of Device Safety
- Develop critical relationships with internal Lilly customers and other GPS functions (e.g., IDM, DDR&D, CPQA, GPS safety management and drug surveillance)
- Identify and influence processes improvements, including the development/design of tools and IT requirements to support device safety activities
- Act as subject matter expert for device related surveillance topics
- Review device surveillance processes, procedures, and/or report templates to ensure compliance with global device regulations.
- Serve as a contact person for groups or individuals having device product related safety questions
- Ensure quality and compliance is maintained
- Understand the roles and responsibilities and ensure support of the EU Qualified Person and EU Authorized Representative for medical devices
Minimum Qualification Requirements:
Any of the following medical related Doctoral or Graduate level degrees: PhD, PharmD, Nursing with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner).
Combined with a minimum of 1 year experience in a related scientific field, e.g. pharmacology, physiology, microbiology.
OR
Bachelor of Science degree in a health-related or scientific field with 7+ years of experience in pharmaceutical industry
Other Information/Additional Preferences:
- Clinical knowledge of various disease states, human physiology, and pharmacology
- Directly related clinical trial experience or experience in areas relevant to drug discovery or development, e.g. epidemiology, toxicology, pharmacovigilance, regulatory affairs
- Experience within Global Patient Safety or demonstrated knowledge and understanding of pharmacovigilance, epidemiology, and device vigilance is preferred
- Ability to manage multiple tasks simultaneously
- Knowledge of major global device safety regulations
- Demonstrated consistent delivery of high quality on time work products
- Working knowledge of drug delivery systems and the product complaint management process
- Clinical knowledge of various disease states, human physiology, and pharmacology
- Strong Analytical/Quantitative Skills
- Effective communication skills to interact with diverse groups and individuals
- Fluency in written and spoken English
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
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