Lilly Medical Review Capability Lead in Bengaluru, India
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 35,000 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.
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 also provide leadership for Medical Review team of Global Patient Safety (GPS) Clinical Case Management (CCM).
Key responsibilities include but not limited to:
i) 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 ii) the medical content of Individual Case Safety Reports (ICSRs) as needed, and making the determination of the sponsors’ assessment of relatedness for applicable ICSRs.
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
iii) Identify or help support evaluation of potential quality issues with Lilly products that may adversely affect patient safety.
iv) 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.
Managerial/Leadership: Provide administrative oversight of medical review activities.
i) Provide strategic insights and technical excellence (i.e., sought as a consultant by functional and cross-functional peers and leaders).
ii) Provide strong medical leadership that influences scientific and process improvements and drive change within the organization.
iii) Facilitate, train and mentor other Medical Reviewers in the responsibilities of the role.
Minimum qualification requirements
i) 7-10 years of experience in pharmaceutical industry, preferably in Pharmacovigilance (Safety) and Medical review of ICSRs. Good clinical experience handling patients is preferred.
ii) Preferably 2-3 years of managerial experience (preferably managing physicians) collaborating with global stakeholders.
iii) Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
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At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!