Analyst - PV

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!

Your Role: Analyst - PV

Your Responsibilities: -

1.

Adverse Event Case Processing - 


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



* 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 events and product complaint case processing and case submission processes as appropriate.  



* Typical case processing activities include (but not limited to): 



* Validation of data entry against source document(s) and call notes as appropriate. 



* Assessment of adverse event reports for seriousness, reportabilities and causality including reason for assessment. 



* Perform self-review of all data for completeness, correctness and quality. 



* Ensuring that the case is considered complete, accurate, and ready for submission to appropriate regulatory authorities. 



* Determine what, if any, follow-up information is needed 



* Ensure to meet the expected productivity and quality standards. 



* Active participation in team meetings.  



* Perform other duties as assigned.  

Skills & Abilities 


* Basic knowledge of medical terminologies and able to understand common medical terms relevant to pharmacovigilance and adverse event reporting.  

2.

Global GPV Support


* Keep current on global regulatory issues and practices related to GPV


* Assist with support of internal partners in GPV related activities as necessary


* Partner and communicate with GPV colleagues


* Management of global adverse events mailbox


* Perform regulatory submissions of individual case reports

3.

Collaboration/Support Internal and External Customers


* Communicate effectively with Elanco contacts from affiliate offices, call center contacts, legal, customer response teams, and other customer groups


* Understand the confidential nature of company informati...