Associate Consultant-Safety Surveillance
Eli Lilly - Indianapolis, IN

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Job Description: Eli Lilly and Company has been dedicated to meeting the health care needs of people in the United States and around the world. We address these needs primarily by developing innovative medicines—investing a higher percentage of our sales in research and development than any other major pharmaceutical company. If you are interested in being considered for employment with a Best in Class Pharmaceutical company, please review the following opportunity. Responsibilities Signal Detection/Clarification Effectively utilize available tools to identify, clarify and communicate potential safety signals from multiple data sources. Consult and coordinate with safety physicians and other appropriate personnel to ensure thorough evaluation of safety signals. Effectively communicate relevant safety information to the appropriate persons. Actively participate in therapeutic area and departmental safety meetings. Safety Inquiries Define evaluation plan with partners (physicians, team members, business partners) to appropriately assess and complete responses for inquiries from both regulatory authorities and other internal and external sources regarding product safety. Periodic Reports/ Pharmacovigilance (PV) Plans Complete the analysis of the safety data related sections and maintain oversight of periodic reports such as Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs) and Ethical Review Board (ERB) Line Listing Reports. Meet periodic reporting requirements as per the periodic reports calendar. Prepare and maintain PV plans. Identify and propose process improvements. Promote and advance the field of Global Patient Safety Develop critical relationships with internal Lilly customers (e.g. product teams, regulatory, GOLD). Develop expertise in surveillance activities and documents and apply shared learning and influence across the surveillance team. Quality and Compliance To have an understanding of the role and responsibilities of the EU Qualified Person To ensure support of the EU Qualified Person to fulfill his/her legal responsibilities.
Basic Qualifications Education: Bachelors degree or higher in the healthcare field (with preference given to pharmacy, medical or nursing) or equivalent demonstrated clinical experience Experience within Global Patient Safety or demonstrated understanding of Pharmacovigilance and Pharmacoepidemiology Clinical knowledge of various disease states, human physiology and pharmacology Strong Analytical/Quantitative Skills Effective communication skills to interact with diverse groups and individuals Demonstrated consistent delivery of high quality on time work products Qualified candidates must be legally authorized to be employed in the United States. Eli Lilly and Company does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. Additional Skills/Preferences Knowledge of global safety regulations Ability to manage multiple tasks simultaneously Additional InformationELI LILLY AND COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER

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At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in...