Associate Manager/ Sr. Associate Manager - Aggregate Report Writing

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.

We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

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!

Company Overview:

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.

We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet, and our enterprise.

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: [Associate/ Senior Associate Manager – Aggregate Report Writing]

As an Associate/ Senior Associate Manager – Aggregate Report Writing, you will be part of Global Pharmacovigilance team to deliver veterinary pharmacovigilance documents for regulatory submission and internal use.

The purpose of this role is to ensure the provision of comprehensive, high quality, scientifically accurate and consistent medical information in consultation with the Global Pharmacovigilance team.

Your Responsibilities:


* Author/review of routine regulatory documents including, but not limited to aggregate reports (PSURs, PDER), Annual Signal Management Reports, and literature searches and occasionally other regulatory documents such as Risk Management Plan, Benefit-Risk Evaluation reports and Ad hoc PSURs required in accordance with applicable regulatory requirements.


* Provide oversight to co-authors or team of writers as applicable and be accountable for the quality of their work/contributions.


* Support Regulatory Affairs team in the timely submission of Regulatory dossier for the initial or renewal of product registrations.


* Ma...