- Parexel (Indianapolis, IN)
- …considered. + Good knowledge/understanding of medical terminology + Relevant experience in pharmacovigilance / Drug Safety / Clinical Practice **Education:** + ... labeling documents, data handling conventions, client's guidelines and procedures, and global drug safety regulations and guidelines + Maintaining an awareness… more
- Parexel (Indianapolis, IN)
- …Experience with **medical monitoring** and clinical trial design/execution + Knowledge of drug safety and pharmacovigilance processes **Essential Skills** + ... feasibility assessments + Contribute medical insights to protocol design and drug development programs + Support pharmacovigilance activities including medical… more
- Sumitomo Pharma (Indianapolis, IN)
- …including authoring clinical sections for INDs, NDAs, and other related documents. + Partner with Drug Safety & Pharmacovigilance to assess the safety ... monitoring overall study integrity, and review, interpretation, and communication of safety and efficacy data. + Present at scientific, medical, and regulatory… more
- Lilly (Indianapolis, IN)
- …health science or information technology) + 2+ years of experience supporting drug development areas (eg, Safety , Clinical, Project Management, Tech@Lilly, ... automation, technology and analytics needs. + Maintain deep technical understanding of safety process knowledge in order apply technology and automation to PV… more
- Sumitomo Pharma (Indianapolis, IN)
- …collaboration with external partners **Key Core Competencies** + Strong understanding of pharmacovigilance regulations and drug safety reporting requirements ... a dynamic, highly motivated, and experienced individual for the position of Pharmacovigilance Scientist to perform PV activities for assigned programs(s). Ability to… more
- Lilly (Indianapolis, IN)
- …industry experience and clinical trial experience, or experience in drug discovery or development (eg, epidemiology, toxicology, pharmacovigilance , ... industry experience and clinical trial experience, or experience in drug discovery or development (eg, epidemiology, toxicology, pharmacovigilance ,… more
- Lilly (Indianapolis, IN)
- …strong publication record. + Proficiency in data analysis and reporting. + Experience in drug safety is not required. **Other Information** + This position is ... industry, government, and academia. The candidate will develop key skills in pharmacovigilance and safety science (particularly with respect to novel… more
- Lilly (IN)
- …functions across the company to leverage learnings, resources, and capabilities. Assurance of Drug Safety Regulatory Compliance + Maintain safety systems to ... information technology field or equivalent experience. + 5+ years experience supporting drug development areas (eg, Safety , Clinical, Project Management, IT,… more
- Lilly (Indianapolis, IN)
- …Education | MBC. Other Information/Additional Preferences: + Clinical development or pharmacovigilance experience preferred. + Knowledge of drug development ... is responsible for conducting comprehensive medical review of Individual Case Safety Reports (ICSRs), ensuring the accuracy, integrity, and compliance of global… more
- Lilly (IN)
- …will have expertise in diabetes, obesity, cardiovascular, renal or endocrinology drug development with demonstrated learning agility, a problem-solving mindset, and ... trials, the reporting of adverse events as mandated by corporate patient safety ; the review process for protocols, study reports, publications and data dissemination… more