The GPS Medical - Case Medical Review Physician in the Americas Regional Center (ARC) will be a full time member of the Global Patient Safety organization. Primary responsibilities for this position include accountability for individual case safety report (ICSR) medical review and collaboration with the GPS Medical – therapeutic area and early phase medicine group physicians/ CRSs and safety surveillance teams (SST) regarding safety surveillance issues. This position is located in Indianapolis. Case Medical Reviewer physicians based in Indianapolis report to the Global Medical Review Group Leader.
Key Objectives / Responsibilities:
Medical support of individual case adverse event and product complaint reporting process
Regional GPS medical leadership
- Provide the medical and clinical expertise necessary to support case managers and call center staff involved in receiving, preparing and reporting adverse events and product complaints
- Provide medical technical expertise in evaluation of adverse events, supporting the case management staff in ensuring appropriate follow-up, reviewing assessments of listedness based on local and global reporting requirements, and being accountable for the medical content of ICSRs.
- To successfully meet these requirements, the case medical reviewer physician will work closely with the GPS Medical - therapeutic area and early phase medicine group physicians and CRSs and SSTs to ensure appropriate communication of safety issues (both locally and globally), the medical quality of ICSRs and participation in the global assessment of the benefit: risk balance of Lilly products.
- 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/product complaints.
- Accountable for sign off on the medical content of ICSRs that require medical review including the determination of the sponsor's assessment of causality for clinical trial ICSRs.
- As the medical representative of GPS for spontaneously reported and clinical trial individual case safety reporting in the Americas Regional Center, 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 CRSs and development SSTs 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 SST s, 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.
- Provide consultation on the design of research studies related to assessment of safety issues.
- Provide input into the safety aspects of USMD-designed clinical studies through participation on their affiliate Protocol Review Committee (PRC), if requested.
- Participate in process development, quality review, continuous inspection and audit preparedness and inspection I audit support, and similar activities in response to a changing regulatory environment or corporate priorities.
- Have an understanding of the roles and responsibility of the EU qualified person and ensure support is provided to fulfill the QP legal responsibilities
- Understanding all aspects of safety management throughout the lifecycle of a molecule.
- Appropriate understanding in the assessment of safety Signals, development of risk management plans, use of pharmacoepidemiology to assess and analyze safety signals, and use of safety databases to analyze safety signals.
- Maintenance of medical expertise in areas of interest or specialty is desirable.
Additional Skills / Preferences:
- 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 certifications.
- 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
- Post-medical graduate training in clinical medicine
- Previous extensive clinical experience
- Strong clinical/diagnostic skills
- Demonstrated success in implementing projects
- Excellent teamwork skills
- Ability to effectively function in a matrix environment
- Strong written, spoken, and presentation communication skills.
- Prior industry experience is preferable but not necessarily in safety (e.g. medical or other functional roles).
- Fluent in English, both written and verbal communications
Lilly credits its exceptional employees for its successes, and knows the key to ongoing achievement lies in attracting and retaining the best people. A company rich in heritage, Lilly employs individuals, conducts research and markets products worldwide. By providing for the unmet needs of our customers through a continuous stream of innovation, we will outgrow all competitors.
- Located in Indianapolis, Indiana
- Willing to engage in domestic and international travel to the degree that is appropriate to support the business of the team.
- Facility in the use of computer-related tools essential (e.g. word processing, e-mail, web browsers).
- Ability to work in a global environment (virtual tools and travel).
Lilly earns consistent and wide recognition for creating an exceptional work environment while maintaining our highly regarded reputation in the Pharmaceutical Industry and Community. The following is a selection of awards and recognition Lilly has received in recent years:
Awards and Recognition
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