Product Safety Manager

Location: Indianapolis

# Product Safety Manager Back to search results

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** At Elanco (NYSE: ELAN) - it all starts with animals!*
* ** As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.*
* ** At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People.*
* ** At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.*
* ** Making animals' lives better makes life better - join our team today!*
* ** Position

Description:

** The Product Safety Manager provides indirect leadership for and performs key functions within the Elanco Animal Health Global Pharmacovigilance Unit.
The individual provides implementation and support to internal and external partners in analysis, interpretation and reporting of adverse event (AE) data. In addition, the individual is responsible for collaborating with PV colleagues to maintain a comprehensive signal management program to ensure product safety at a global level.
This individual works effectively and flexibly within and across Elanco teams and external collaborators to achieve Elanco pharmacovigilance deliverables.

** Functions, Duties, Tasks:*
* ** Technical duties:*
* * Acts as subject matter expert of commercially available PV tools to further enhance the signal management process in Elanco.
* Responsible for review, and analysis of individual case reports, aggregate safety data, signal detection, and risk management activities concerning the product portfolio.
* Evaluates and interprets aggregate safety data for aggregate reports, signal management activities, Risk Management Plans, other labeling documentation and other routine and non-routine safety and benefit-risk evaluations for internal or regulatory purposes as required.
* Represents Elanco in the preparation and participation of internal and external pharmacovigilance audits and inspections.
* Ability to independently prioritize to ensure the objectives are achieved on time with efficient use of resources.  + Staying current and providing forwarding thinking on signal management including interrogating external databases (e.g. open FDA, EVVET) to improve statistical power  + Acts as a coach/mentor to provide expertise to other team members and external customers as applicable  + Lead the technical review and interpretation of scientific data for assigned products as required.

Network with and provide guidance to teams working on new product development, global marketing, and hypercare teams
* Is accountable for bringing suspected safety concerns, potential trends and signals to the appropriate safety committee, and making recommendations for risk mitigation/management.
* Responsible for the preparation, interpretation and presentation of drug safety aggregate data reports, to internal and external customers and global regulatory authorities as required.
* Leads or contributes to PV projects to assure safety information drives labelling and promotional material changes for currently marketed products, as required.
* Leads training of less experienced internal and cross-functional team members, encouraging them to be successful and productive.
* Able to summarize and present complex technical information succinctly to encourage increased understanding and contributions from others.
* Contribute to the furthering of Pharmacovigilance Signal Management within the company by staying abreast of state-of-the-art methodology in the external environment, changes in the regulatory environment and developments. Applies this knowledge for the benefit of the function.

** Additional Expectations:*
* * Comply with all company local and global policies, including Quality frameworks, Code of Conduct, Corporate Citizenship, anti-discrimination, harassment, and Health, Safety and Environment (HSE) policies
* Create a positive work environment that is aligned with company objectives, visibly aligns work with company goals and encourages others to do the same.
* Develops and drives the technical capabilities of self and team to improve PV decision making, particularly in areas of ambiguity. Remains calm and productive when dealing with problems that do not have clear solutions, adapts quickly to changing conditions.
* Support colleagues at affiliate sites to ensure pharmacovigilance compliance.
* Perform any other duties or projects as requested by the Line Manager commensurate with the grade and level of responsibility for this role, for which the employee has the necessary…