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):

Perform 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

Determination of whether GPV review is necessary

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

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

Participate in workgroup meetings and follow-up activities for assigned project, if required

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 information and take necessary steps to ensure its protection

Ensure that an appropriate confidentiality agreement has been executed before disclosing confidential company information to outside parties

Minimum Qualification (education, experience and/or training, required certifications):

Veterinarian (BVSc/MVSc/equivalent to US DVM degree)

0-2 years experience in veterinary pharmacovigilance.

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