Medical Advisor, Global Patient Safety - Diabetes portfolio
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. You will be 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.
Product or Molecule Safety Physician / Lead Physician
Offer global medical leadership and input into all aspects of safety of assigned product(s) including surveillance programs and risk management planning.
Ensure dedicated safety surveillance.
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 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.
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 GPS 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 GPS curriculum map.
Maintaining compliance with the Lilly Corporate Integrity Agreement.
Global Patient Safety Leadership
Contribute input to GPS Leadership Team and Safety Review Committee as required; actively contribute to the management of Global Patient Safety at strategic level.
Provide ad-hoc involvement in operations, if required.
Act as the Lilly GPS Medical Representative for both internal and external customers, interacting as prescribed in corporate guidelines and policies
Represent Global Patient Safety within the company and externally; and Review and comment on external regulatory policy and trends affecting Global Patient Safety
Additional Skills/Preferences :
Clinical research or pharmaceutical medicine experience 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 build 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
Good communication skills, both verbal and written
Ability to effectively function in a matrix environment
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.
- 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).
- Clinical research or pharmaceutical medicine experience 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
- Team player
- Ability to effectively function in a matrix environment
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.