Global Medical Review Physician - Senior Director
Eli Lilly
- Indianapolis, IN
- Permanent
- Full-time
- Provide the medical and clinical expertise necessary to support Safety Management Associates and staff involved in receiving, preparing, and reporting adverse events.
- Provide medical technical expertise in evaluation of adverse events, supporting the case management staff in ensuring appropriate follow-up, reviewing assessments, and providing review for the medical content of Individual Case Safety Reports (ICSRs) as needed, and making the determination of the sponsors’ assessment of relatedness for applicable ICSRs.
- To successfully meet these requirements, the Global Medical Reviewer will work closely with the GPS Medical - therapeutic area and early phase medicine group physicians and scientists to ensure appropriate communication of safety issues (both locally and globally) and the medical quality of ICSRs.
- Identify or help support evaluation of potential quality issues with Lilly products that may adversely affect patient safety.
- Assist in supporting customer response activities associated with adverse events.
- As a medical representative of GPS for spontaneously reported and clinical trial individual case safety reporting, contribute to the global assessment of safety of Lilly products and molecules in clinical trials by interacting directly with the GPS Medical - therapeutic area and early phase medicine group physicians and scientists involved in assessing the safety profile of Lilly products. This responsibility requires regular participation (in person or by teleconference) in relevant GPS global scientific and surveillance meetings related to management of marketed product and developmental product safety.
- Assist safety surveillance teams in review of specific individual ICSRs, bringing clusters of ICSRs from clinical trials suggesting a safety signal to the attention of Safety Surveillance Teams (SSTs), understanding case management specific issues and regulatory constraints, and conveying to the remainder of the Global Medical Review Group compound or trial specific issues and concerns.
- Build collaborative working relationships with other physicians and scientists in GPS Medical as well as Development and Brand Teams globally to ensure full cooperation and high-quality medical evaluation of safety data for global regulatory purposes.
- Provide strategic insights and technical excellence (i.e., sought as a consultant by functional and cross-functional peers and leaders).
- Have a strong foundational knowledge of pharmaceutical industry, including understanding of relevant aspects of the regulatory, industry, and scientific environments, laws, regulations, and guidance.
- Provide strong medical leadership that influences scientific and process improvements and drive change within the organization.
- Facilitate, train and mentor other Medical Reviewers in the responsibilities of the role.
- Understand the roles and responsibility of the European Union Qualified Person for Pharmacovigilance (QPPV).
- Ensure support is provided to enable the QPPV to fulfil the QP legal responsibilities.
- Meet the Research & Development (R&D) Titles Expectations as outlined in the R&D Titles Framework at their respective levels. Maintain medical expertise in areas of interest or specialty. Understand and comply with all compliance policies, laws, regulations, and the Red Book. Adapt to the changing global regulatory environment. Understand the confidential nature of company information and take necessary steps to ensure its protection. Ensure that an appropriate confidentiality agreement has been executed before disclosing confidential company information to outside parties.
- The 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. Non-US trained physicians hired in the US 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 written, spoken, and presentation communication skills.
- Previous extensive clinical experience is essential.
- Facility in the use of computer-related tools essential (e.g. word processing, e-mail, web browsers).
- English language skills - fluent written and verbal communications.
- Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
- Ability to work in a global environment (virtual tools and travel).
- Excellent teamwork skills.
- Willing to engage in domestic and international travel to the degree appropriate to support the business of the team.