Director of Pharmacovigilance – North America (PV-NA)  at Elanco in greenfield, Indiana

Job Description:

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: Director of Pharmacovigilance – North America (PV-NA) 
 

As the Director of Pharmacovigilance – North America (PV-NA), you will lead and oversee all Elanco pharmacovigilance activities in the United States (US) and Canada (CA), ensuring compliance and trust by regulators and customers to safeguard Elanco’s product portfolio. You'll be responsible for managing, coordinating, and supporting the NA PV Team, providing direction to internal and external partners, and representing GPV at the local level. 

Your Responsibilities: 

• Ensure PV compliance in the US and CA, aligning with local legal requirements and global regulations, as well as internal Elanco PV standards. Serve as the Local PV Manager (LPVM) for the US, overseeing the NA PV Team and providing support as needed. 




• Cultivate relationships with internal and external stakeholders, including Product and Veterinary Support teams, and regulatory authorities (e.g., US FDA, USDA, US EPA, Canadian Regulatory Authorities), to uphold compliant local PV systems. Collaborate with Elanco GPV to advocate for Elanco’s interests in local Industry Associations. 




• Manage the NA PV Team, directing project prioritization, resource planning, recruitment, and performance management to ensure efficient operations and development opportunities. 




• Ensure proper PV training for the NA PV Team and external partners, acting as the local point of contact for third parties with PV Agreements (PVAs) with Elanco. Represent GPV locally, conveying local and regional PV requirements, issues, and trends to GPV functions. 




• Coordinate with Product Safety Management and Data Processing Management Teams to facilitate the submission of periodic safety monitoring reports and review local research and post-marketing studies protocols, ensuring compliance and accuracy. 

What You Need to Succeed (minimum qualifications): 

• Education: DVM, medical degree/science degree, or PhD or Master's degree in a relevant scientific field applicable to animal health and pharmacovigilance. 




• Required Experience: A minimum of 5 years’ experience in pharmacovigilance or 10 years’ experience in a related field in the animal health industry.  




• Top 2 skills: Excellent leadership skills and strong communication abilities.  

What will give you a competitive edge (preferred qualifications): 

• Experience in Regulatory Affairs and/or Quality, with interaction with regulatory health authorities.  




• Solid understanding of animal health business and operations, including potential critical issues that must be managed.  




• Demonstrated ability to effectively manage and navigate within a matrix organization. 




• Previous experience in managing pharmacovigilance activities in the animal health industry.  

Additional Information: 

Travel: Domestic & International Travel may be required (10%) 

Location: Global Elanco Headquarters - Greenfield, IN - Hybrid Work Environment  

Don’t meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco, we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles! 

Elanco Benefits and Perks: 

We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include: 

• Multiple relocation packages  




• Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)  




• 8-week parental leave  




• 9 Employee Resource Groups  




• Annual bonus offering  




• Flexible work arrangements  




• Up to 6% 401K matching 

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status