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 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.

The purpose of Global Patient Safety (GPS) Global Medical Review Senior Director role is to be a full-time member of the Global Patient Safety (GPS) organization. Primary responsibilities for this position include accountability for local safety related responsibilities, collaboration with the GPS Medical physicians and scientists regarding safety surveillance issues and, if applicable, provide leadership for Global Patient Safety (GPS) Safety Management, Reporting and Safety Data Sciences (SMRD).

Primary Responsibilities:

Medical support of individual case adverse event reporting process

• 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.

GPS Medical Leadership

• 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.

Participate in process development, quality review, continuous inspection and audit preparedness and support, and similar activities in response to a changing regulatory environment or corporate priorities.

Act as the Lilly GPS Medical Review representative for both internal and external customers, interacting as described in corporate guidelines and policies.

Build strong relationships with key customers, representing and championing the role of safety in the organization.

As appropriate, provide leadership for Safety Management, Reporting, and Safety Data Sciences (SMRD). This leadership might be provided through technical and/or administrative oversight of global case management activities.

• 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.

Understanding and support of the QPPV 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.

Other Job expectations

• 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.

Minimum Qualification Requirements:

• 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 http://www.in.gov/pla/2799.htm

Other Information/Additional Preferences:

• 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.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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