Jobs
>
Indianapolis

    Associate Director – Device Safety Scientist Global Patient Safety - Indianapolis, United States - Lilly

    Default job background
    Full time
    Description

    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
  • 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.

    Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

    #WeAreLilly



  • Eli Lilly and Company Indianapolis, United States

    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 th ...


  • Eli Lilly and Company Indianapolis, United States Full time

    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 th ...

  • CorsoCare

    Registered Nurse

    14 hours ago


    CorsoCare Indianapolis, IN, United States

    Admissions Nurse - Hospice - Registered Nurse · Looking to be part of something unique? Bring your Hospice talent to CorsoCare Hospice and SHINE · Job Status: Full Time · MUST HAVE PRIOR IN HOME HOSPICE EXPERIENCE · Free CEU's · Comprehensive benefits · Generous PTO/Holiday (23 d ...


  • Indiana University Health Indianapolis, United States

    Registered Nurse- Radiology (various shifts)- University Hospital- Relocation Incentives · Job Description · Overview · Indiana University Health is looking for passionate, experienced nurses and upcoming/recent RN graduates to join our team and collaborate with top medical profe ...


  • Ascension Indianapolis, United States Full time, Part time

    The Care Group Billing Office - Central Business Office, part of Ascension Living brings it all together for you at our beautiful community. You will have access to personalized care, exceptional services with a balance of city comforts, cultural opportunities and more, in our co ...


  • Ascension Indianapolis, United States Full time, Part time

    ST. VINCENT INDIANAPOLIS ADMIN, part of Ascension Living brings it all together for you at our beautiful community. You will have access to personalized care, exceptional services with a balance of city comforts, cultural opportunities and more, in our community and close by. · W ...

  • Ortho Indy

    Physical Therapist

    2 weeks ago


    Ortho Indy Indianapolis, United States Full time

    Facility : OrthoIndy Hospital, Indianapolis, IN · Department : OIH Physical Therapy, Inpatient · Shift Details : Full-time, 40 hours per week with occasional Saturday rotation. Full benefits included · Great people are the backbone to great care and patient satisfaction. In re ...


  • Harbor Oaks Indianapolis, United States

    OverviewOptions Behavioral is seeking a experienced Director of Risk Management to join the team · As the Director of Risk Management you will plan, organize, direct and control all aspects of risk management activities. · Ensure a safe environment for the protection of patient ...


  • Ascension Indianapolis, United States Full time, Part time

    Hiring for FT, PT, and PRN, 8 hr shifts, All shifts · Care Team C CHF-General, part of Ascension is looking for caring and compassionate Certified Nursing Assistants (CNAs) to join our team · We're the second-largest nonprofit system in the U.S., employing more than 150,000 assoc ...


  • Ascension Indianapolis, United States Full time, Part time

    Hiring for FT, PT, and PRN, 8 hr shifts, All shifts · AscensionPRIMARY CARE CENTER OB GYN, part of Ascension is looking for caring and compassionate Certified Nursing Assistants (CNAs) to join our team · We're the second-largest nonprofit system in the U.S., employing more than 1 ...


  • Edwards Lifesciences Indiana, United States Full time

    Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientif ...


  • Justice, Bureau of Prisons/Federal Prison System Marion, United States

    Summary · Corrections professionals who foster a humane and secure environment and ensure public safety by preparing individuals for successful reentry into our communities. · Our highly-skilled, diverse, and innovative workforce creates a strong foundation of safety and securit ...


  • Altra Homecare Group Indianapolis, United States Full time, Part time

    Altra Homecare Group Indianapolis, IN 46250 · Looking for: Full/ Part time/ Per Diem · Description: Personal Care Attendant will perform homecare duties. These duties require personal care services necessary to meet the patient's needs. PCA responsibilities will include, but are ...

  • Altra Homecare Group

    Home Health Aide

    1 day ago


    Altra Homecare Group Indianapolis, United States Full time, Part time

    Home Health Aide / Certified Nursing Assistant · Altra Homecare Group · Indianapolis, IN 46250 · Job Details · Full/ Part time/ Per Diem · Description: · Home Health Aides (HHA) will perform homecare duties. These duties require personal care services necessary to meet the patien ...


  • Ortho Indy Indianapolis, United States Full time

    Facility : OrthoIndy Hospital Main, Indianapolis, IN · Department : OIH Inpatient Services · Shift Details : Full-timenight shift, three 12 hour shifts per week, 7:00 pm - 7:30 am and 4 weekendnight shifts per 6 week schedule. Great nurse to patient ratio and nightand weekend n ...

  • Soliant

    Retail Pharmacist

    2 weeks ago


    Soliant Indianapolis, United States

    Minimum 1+ years pharmacy experience required. · Are you ready to make a difference in healthcare? Soliant Health is currently seeking a skilled Retail Pharmacist to join our team in a Long-Term Care Pharmacy setting. If you have a passion for providing exceptional pharmaceutical ...

  • Soliant

    CVOR Registered Nurse

    2 weeks ago


    Soliant Indianapolis, United States

    Minimum 1+ years nursing experience required. · CVOR Registered Nurse (RN) - Indianapolis, IN · "The best way to predict the future is to create it." - Peter Drucker · Are you an experienced CVOR Registered Nurse (RN) seeking an exciting opportunity in the vibrant city of Indiana ...

  • Eskenazi Health

    STAFF NURSE II

    2 weeks ago


    Eskenazi Health Indianapolis, United States Part time (noben) 22

    This position is PRN and MUST be able to work Thursdays. Other days will be necessary but Thursdays are required. This nurse will serve in the Burn Center supporting peri-op/recovery for the Burn Operating Rooms. · The Staff Nurse II provides clinical care and uses coordination ...


  • Franciscan Health Indianapolis, United States Full time

    Franciscan Health Indianapolis Campus 8111 South Emerson Avenue Indianapolis, Indiana 46237 WHAT WE NEED · CT Technologist Monday - Friday 2:30p-11:00p · WHO WE ARE LOOKING FOR · Computerized Tomography Scans are important diagnostic tools for physicians. Those physicians r ...


  • No Selection Indianapolis, United States Full time (w/ben) 11

    The Team Captain RN and Triage Nurse RN are positions that allow for a collaborative approach to the patient's healthcare in a multitude of ways. · Team Captain RN - This role is for the nurse responsible for the overall care of patients assigned to their team's providers. This ...