Pharmacovigilance (PV) Director – Regulatory

Elanco Clinton Laboratories

Indianapolis, IN

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: Pharmacovigilance (PV) Director - Regulatory

As the Pharmacovigilance (PV) Director - Regulatory, you will be part of the Elanco Animal Health Global Pharmacovigilance Unit. In this role, you’ll be responsible for advancing the collection, analysis, interpretation, and reporting of adverse event (AE) data, and developing a comprehensive signal detection and trending program to ensure product safety globally.

Your Responsibilities:

  • Acts as subject matter expert for PV tools like PVWorks to enhance Elanco's signal management process.

  • Reviews and analyzes individual case reports, aggregate safety data, signal detection, and risk management activities.

  • Evaluates aggregate safety data with Signal Management members and Product Stewards, contributing to reports and risk evaluations.

  • Represents Elanco in internal and external pharmacovigilance audits and inspections.

  • Independently prioritizes tasks to achieve objectives efficiently.

  • Brings safety concerns and potential trends to the Signal Management Team, recommending risk mitigation strategies.

  • Supports responses to regulatory authorities and inquiries from PV stewardship groups and internal/external sources.

  • Leads signal detection training and mentors less experienced team members, promoting productivity and understanding.

  • Complies with company policies, creates a positive work environment aligned with company objectives, and adapts to changing conditions.

What You Need to Succeed (minimum qualifications):

  • Education: Doctor of Veterinary Medicine (DVM), or a Biological Science to Master Level or equivalent experience.

  • Experience: A minimum of five years’ clinical veterinary practice or animal health experience. Ability to evaluate large databases and design systems to extract datasets relevant to various business needs.

  • Top 2 skills: Expertise in commercially available PV tools and signal management. Strong analytical skills in reviewing and interpreting safety data.

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

  • A degree or industry experience in biostatistics.

  • Experience in interpreting regulations, guidelines, and policies.

  • Proven ability to summarize and present complex technical information succinctly.

  • Experience in leading signal detection training curriculum and mentoring team members.

  • Knowledge of state-of-the-art pharmacovigilance methodology and regulatory developments.

Additional Information:

  • Travel: Up to 10% annually

  • 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