Clinical Research Physician, GPS Medical
Eli Lilly
- Indianapolis, IN
- Permanent
- Full-time
- Provide GPS Medical leadership and input into all aspects of safety of assigned compounds and products including surveillance programs and risk management planning.
- Ensure proactive safety surveillance:
- 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 Products Labeling Committee and/or the Safety Review Committee as appropriate.
- Build collaborative working relationships with other GPS Medical physicians and development and brand teams medical globally to ensure full cooperation and high-quality medical evaluation of safety data for global regulatory purposes:
- Demonstrate knowledge in pharmacovigilance and risk minimization, which includes understanding of relevant aspects of the regulatory industry and scientific environments, laws, regulations and guidance.
- 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 Qualified Person to fulfill all the Qualified Person legal responsibilities.
- 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 Medical training for development and brand team physicians and clinical research scientists and other audiences (e.g. Regulatory, 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.
- Provide input to Global Patient Safety Medical Leadership Team and Safety Review Committee as required; actively contribute to the management of Global Patient Safety at strategic level.
- Build strong relationships with key customers, representing and championing the role of safety in the organization:
- 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
- Strong clinical/diagnostic skills.
- Demonstrated success in implementing projects.
- Good communication skills, both verbal and written.
- Team player.
- 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.
- Ability to effectively function in a matrix environment.