Associate-Pharmacovigilance - United States
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|Elanco is a global research-based company that develops and delivers product and services to enhance animal health and production. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 7,000 employees worldwide. Founded in 1954, Elanco is a division of Lilly. Our worldwide headquarters and research facilities are in Greenfield, Indiana.|
|The Pharmacovigilance Associate provides leadership for and performs key functions within the Elanco Animal Health Global Pharmacovigilance Unit. The individual provides direction to internal and external partners in the collection, analysis, interpretation and reporting of adverse event (AE) data. |
Functions, Duties, Tasks:
Key Leadership Responsibilities:
• Proactively search for solutions.
• Work effectively and flexibly within and across all Elanco R&D teams and external collaborators to achieve over Elanco R&D deliverables.
• Lead the enhancement of work flow practices to increase data robustness while promoting efficient work flow practices.
• Provide and accept challenge to deliver innovative technical solutions and create an innovative culture.
• Collaborate with global colleagues to develop a global strategy and work flow processes for adverse event reporting.
• Develop strategic plan for increased utilization of commercially available PV tools (such as PVWorks and all available applications) to further streamline the adverse event data collection process on a global basis.
• Create a positive work environment that is aligned with company objectives.
• Create an engaging culture with a "Play to Win" mentality.
Key Technical Responsibilities:
• Develop knowledge of USDA regulations and remain up to date on regulation changes.
• Perform vaccinovigilance activities for USDA licensed products.
• Participate in signal detection and trending (SDT) for assigned products.
• Extensive knowledge of the AEGIS database and associated tools used to report adverse events to appropriate regulatory bodies.
• Maintain positive business collaboration and influence with Elanco US Affiliate, key regulatory agencies, and industry groups.
• Self-management skills in an environment with diverse needs and demanding timelines.
• Strong oral and written communication skills and attention to detail in review and submission of regulatory reports.