Product Safety Manager

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: Product Safety Manager - Signal Detection and Data Assembly Team

As a Product Safety Manager within the Global Pharmacovigilance team, you will be responsible for the compilation, review, validation, and analysis of safety data from internal and external sources to ensure the availability of high-quality evidence for robust benefit-risk assessments of non-High Profile Products (non-HPPs).

The primary responsibility of this role is to conduct systematic surveillance and review of scientific literature to identify, assess, and document safety information related to medicinal products.

The role supports regulatory compliance, signal detection activities, and ongoing benefit-risk evaluation by ensuring that relevant adverse event reports, emerging safety concerns, and published safety data are accurately identified, evaluated, and communicated to appropriate pharmacovigilance stakeholders.

 

Additionally, the role provides support for other global pharmacovigilance activities, including aggregate report preparation, safety case review, and sales data compilation, as required, to support comprehensive safety assessments and regulatory submissions.

Your Responsibilities:


* Conduct literature surveillance and critical review activities to support signal detection, safety monitoring, and aggregate report preparation.


* Identify, evaluate, and document safety information from scientific and medical literature in accordance with pharmacovigilance requirements.


* Assess and communicate relevant adverse event reports, emerging safety concerns, and published safety data to support pharmacovigilance decision-making and regulatory compliance.


* Support benefit-risk evaluations through the analysis, interpretation, and synthesis of published safety data, ensuring high-quality documentation and timely completion of literature review activities.


* Collaborate with cross-functional stakeholders to support safety assessments, risk evaluations, and regulatory reporting requirements.


* Author and review aggregate reports and other regulatory safety documents, including Annual Signal Ma...