Analyst- Pharmacovigilance-4

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 Analysṭ - PV Case processing, is responsible for adverse event and product complaint report handling.

This includes assessing and processing individual adverse event and product complaint reports; maintaining awareness of global pharmacovigilance regulations; ensuring regulatory compliance for expedited submission of individual case reports; collaborating with internal and external business partners; as well as other duties as assigned.

A case processor’s responsibilities can vary depending on the needs and focus of a particular team.

Functions, Duties, Tasks:

1.

Adverse Event Case Management


* Responsible for data entry, assessment, management, and submission of adverse event reports in the PV database


* Responsible for the completeness and accuracy of data collection and entry, case assessment, and other associated case management activities


* Identifies issues in case processing that may result in a delay in submission and escalates issues to management as appropriate


* Develop an understanding of pharmacovigilance regulations


* Comply with internal and external timelines for managing adverse event and product complaint data entry, case processing, and case submission processes as appropriate


* Typical case management processing activities include (but not limited to):
+ Validate/perform data entry against source document(s) as appropriate
+ Creation of a case narrative
+ Identify concomitant medications and relevant medical history


* Additional case management activities may include (but not limited to):
+ Completion of case management activities related to business partnerships as necessary
+ Attempt to obtain follow-up information from external parties through effective written and oral communications
+ Perform typical case management assessment activities which include (but not limited to):
o Perform review of all data for completeness, correctness and quality
o Ensuring that the case is considered complete, accurate, and ready for submission to ap...