Courtney Kulp
Greenfield
Summary
Global Veterinary Regulatory and Pharmacovigilance Professional Results-driven animal health expert with deep knowledge of U.S. and international pharmaceutical regulations for the development, study, and commercialization of veterinary products. Skilled in pharmacovigilance, signal detection, adverse event management, and both individual and aggregate regulatory reporting, with a strong record of fostering positive regulatory relationships. Trusted mentor and collaborative team player, supporting colleagues’ growth and contributing to a high performing, engaging, and supportive work environment across the U.S., UK, EU, Canada, South America, Australia, and New Zealand.
Overview
21
21
years of professional experience
Work History
Product Safety Manager
Elanco Animal Health
Greenfield
02.2020 - Current
- Ensured regulatory compliance for companion and farm animal product portfolios across US, EU, and post-Brexit frameworks, including 21 CFR 514.80, 9 CFR 116.9, 40 CFR Part 159, EU Volume 9B, and New Veterinary Regulation (EU) 2019/6.
- Led analysis of adverse event data to identify safety signals and trends, delivering actionable recommendations for risk mitigation and benefit-risk assessment.
- Provided scientific and statistical interpretation of pharmacovigilance data, supported literature surveillance, and addressed global pharmacovigilance information requests.
- Oversaw compliance-related initiatives, including label and SPC defense, EMA QRD revisions, PSUR submissions (EU/Australia), and Direct-to-Consumer campaign oversight.
- Leveraged SAP and data analytics tools to estimate treated populations and support regulatory reporting.
- Influenced corporate pharmacovigilance strategy during Bayer acquisition, directing PV-IT integration testing, database guidance revisions, and interim guidance-sharing platforms to drive efficiency and compliance.
Manager, Veterinary Pharmacovigilance
Kindred Biosciences
Burlingame
09.2018 - 10.2019
- Developed and maintained signal detection and trending programs to ensure product and animal safety.
- Directed internal and external partners in collection, analysis, interpretation, and reporting of adverse events and product complaints.
- Communicated with veterinarians, support staff, internal teams, and animal owners regarding product inquiries, quality issues, and suspected adverse events.
- Provided technical and medical support to sales representatives and development teams, offering safety insights in post-approval products.
- Built transparent regulatory relationships with FDA-CVM and OSandC; participated in industry working groups to influence strategic guidance.
- Reviewed study protocols, validated scientific statements in promotional materials, and contributed to periodic safety reports for regulatory agencies.
Research Scientist/NA Pharmacovigilance/Global Pharmacovigilance
Elanco Animal Health
Greenfield
06.2014 - 08.2018
- Maintained regulatory compliance for companion and food animal product portfolios under 21 CFR 514.80 and EU Volume 9B.
- Served as key point of contact for newly acquired colleagues, aligning multiple databases to streamline compliance, reporting, and data analysis.
- Liaised with Regulatory team for coordinated ADUFA reporting to FDA-CVM and contributed to industry working groups.
- Designed and managed pharmacovigilance information request system, prioritizing internal data needs and enabling faster risk assessment.
- Provided scientific and statistical interpretation of pharmacovigilance data to support internal stakeholders, including animal welfare committees.
Associate Senior Consultant for Technical, Academic, and Consumer Services
Elanco Animal Health
Greenfield
04.2012 - 05.2014
- Delivered technical support for companion animal products to external consumers and internal stakeholders, resolving inquiries and ensuring accurate adverse event reporting.
- Managed adverse event case creation and submission, maintaining compliance and data integrity.
- Conducted product training for internal teams and shared technical expertise at national, state, and local veterinary meetings.
- Proactively recommended workflow improvements to enhance efficiency and accuracy of data collection and reporting.
Associate Veterinarian
New Palestine VC/Veterinary Centers of America/AMC
New Palestine
05.2005 - 04.2012
- Delivered comprehensive medical care with a focus on client financial needs.
- Conducted annual wellness exams while educating pet owners about health maintenance and disease prevention.
- Managed critical emergency cases with swift hospital admissions and procedures.
- Executed routine surgeries alongside complex procedures, including entropion repair and intestinal resections.
- Applied digital radiography techniques and utilized veterinary software (Cornerstone) for diagnostics.
- Honored as most requested associate veterinarian due to exceptional clinical skills and client relationships.
- Informed pet owners on general health management to promote proactive care.
Education
Doctor of Veterinary Medicine -
Ross University School of Veterinary Medicine
St. Kitts, WIPre-veterinary studies -
Purdue University
West Lafayette, INBachelor of Business Administration (BBA) -
Loyola University of Chicago
Chicago, ILSkills
- Global regulatory leadership
- Regulatory compliance
- Risk assessment and identification
- Data analytics and integrity
- Pharmacovigilance and signal detection
- Adverse event reporting
- Relationship management
- Strategic communication
- Problem solving and attention to detail
- Team collaboration and cross-functional teamwork
- Workflow improvement strategies
- Data-driven decision making
- Systems expertise
Affiliations
- American Veterinary Medical Association, 01/01/02, present
- Indiana Veterinary Medical Association, 01/01/06, present
- Animal Health Institute - Affiliate Member, 01/01/14, present
Timeline
Product Safety Manager
Elanco Animal Health
02.2020 - Current
Manager, Veterinary Pharmacovigilance
Kindred Biosciences
09.2018 - 10.2019
Research Scientist/NA Pharmacovigilance/Global Pharmacovigilance
Elanco Animal Health
06.2014 - 08.2018
Associate Senior Consultant for Technical, Academic, and Consumer Services
Elanco Animal Health
04.2012 - 05.2014
Associate Veterinarian
New Palestine VC/Veterinary Centers of America/AMC
05.2005 - 04.2012
Doctor of Veterinary Medicine -
Ross University School of Veterinary Medicine
Pre-veterinary studies -
Purdue University
Bachelor of Business Administration (BBA) -
Loyola University of Chicago