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.
The purpose of the GPS Senior Medical Advisor/ Medical Advisor is to perform medical roles within the Global Patient Safety (GPS) Medical function. These include performing as the Product or Molecule Safety Physician/Lead Physician, training /coaching /mentoring and demonstrating Global Patient Safety expertise. He or she is the Eli Lilly & Co. GPS Medical Area representative for both internal and external customers regarding a product or molecule, interacting as prescribed in corporate guidelines, standards and policies. Individualized responsibilities for a particular product or project will be discussed and agreed at an individual level.
Key Responsibilities
Product or Molecule Safety Physician / Lead Physician
Provide global medical leadership and input into all aspects of safety of assigned product(s) including surveillance programs and risk management planning.
Ensure proactive safety surveillance:
lead risk management activities for assigned products globally
lead and guide the surveillance activities of scientists on the team including signal detection and clarification activities and risk evaluation activities; provide support, training and continued improvement as appropriate
manage decisions and actions to be taken, including communication to appropriate customers (e.g., Product Teams, Management, Affiliates and Regulators) and
liaise with GPS Medical Area Directors and with Lilly Medical Therapeutic Area Team Leaders and Directors, as appropriate, to fulfill safety obligations;
Supervise and review reports on safety issues and their implications for the Core Safety Information and Core Risk Minimization Activities, represent PV position to Global Patient Labeling Committee and/or the Safety Review Committee as appropriate.
Build collaborative working relationships with other Global Patient Safety Physicians and development and brand teams medical globally to ensure full cooperation and high quality medical evaluation of safety data for global regulatory purposes.
Represent GPS Medical and/or Product on appropriate committees/product development and brand teams.
Provide medical support for Global Patient Safety activities and reports within the department, as appropriate.
Provide Global Patient Safety expertise to internal customers (e.g., regulatory, early phase development, business units).
Provide medical input for review of Adverse Event cases.
Lead process and provide medical input for review of Suspected Adverse Reactions
Demonstrate knowledge in pharmacovigilance and risk minimization, which includes understanding of relevant aspects of laws, regulations and guidance.
Understanding and Support of the QPPV role
Understanding the roles and responsibilities of the European Union Qualified Person (QPPV) and ensure their involvement in the pharmacovigilance system and processes.
Ensure support and information are provided to enable the QPPV to fulfill all the QPPV legal responsibilities.
Training, Coaching, Mentoring
Provide training, coaching and mentorship to safety surveillance scientists, and other GPS Medical physicians and clinical research scientists with respect to medical aspects of safety surveillance
Provide Global Patient Safety training for development and brand team physicians and clinical research scientists and other audiences (e.g. Regulatory, Lilly Medical) as appropriate.
Maintain compliance with Lilly Red Book and corporate policies, Lilly Research Laboratories and Global Patient Safety curriculum map.
Maintaining compliance with the Lilly Corporate Integrity Agreement.
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.
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.