24 days old

Senior Medical Advisor, Immunology / Rheumatology - Global Patient Safety

Indianapolis, IN
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43308
Senior Medical Advisor, Immunology / Rheumatology - Global Patient Safety
Indianapolis
Indiana
United States
North America
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 39,000 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.

Responsibilities
Lilly is seeking a Global Patient Safety Senior Medical Advisor to serve as a Product or Molecule Safety Physician/Lead Physician within our Autoimmune portfolio. In this role, you will get the opportunity to:

  • Offer global medical leadership and input into all aspects of safety of assigned product(s) including surveillance programs, risk management planning and risk management activities.
  • Guide the surveillance activities of scientists on the team including signal detection and clarification activities and risk evaluation activities.
  • Manage decisions and actions to be taken, including communication to appropriate customers (e.g., Product Teams, Management, Affiliates and Regulators)
  • Collaborate with GPS Medical Area Directors and with Lilly Medical Therapeutic Area Team Leaders and Directors, as appropriate, to fulfill safety obligations.
  • Oversee 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 GPS physicians and development and brand teams globally to ensure full cooperation.
  • Provide high quality medical evaluation of safety data for global regulatory purposes.
  • Provide GPS expertise to internal customers (e.g., regulatory, business units, etc).
  • Deliver medical input for review of Adverse Event cases.
  • 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 legal responsibilities.
  • Provide GPS training for development and brand team physicians and CRS and other audiences (e.g. Regulatory, Lilly Medical) as appropriate.
  • Build positive relationships with key customers, representing and championing the role of safety in the organization.
  • Represent Global Patient Safety within the company and externally; and Review and comment on external regulatory policy and trends affecting Global Patient Safety.
43308BR
  • Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring.
  • US trained physicians must have achieved board eligibility or certification. Foreign medical graduates (in US based jobs) who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer.
  • Non-US trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see http://www.in.gov/pla/2799.htm
  • Clinical research or pharmaceutical medicine experience preferred
  • Rheumatology or Immunology specialty strongly preferred
  • Knowledge of drug development process
  • Fluent in English; both written and verbal communications
  • Excellent interpersonal, organizational and negotiation skills
  • Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
  • Excellent teamwork skills.
  • Willing to engage in domestic and international travel to the degree appropriate to support the business of the team.
  • Strong clinical/diagnostic skills
  • Demonstrated success in implementing projects
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.
Posted: 2018-12-26 Expires: 2019-01-26

As one of the oldest continuously operating companies in the United States, we are proud of all the innovative work we’ve accomplished for the last 140 years to improve global health.

We are looking forward to an even more successful future in which continued innovation and contributions from top talent in all areas of our organization will be critical.

Are you looking for a way to make life better for people around the world? We have opportunities in many areas of our organization. Please use the search feature to see the wide scope of our positions.

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Senior Medical Advisor, Immunology / Rheumatology - Global Patient Safety

Lilly
Indianapolis, IN
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