Senior Global PV Policy, Regulation and Compliance manager, Deputy QPPV (EU)

Elanco

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!

The Senior Global PV Policy, Regulation and Compliance manager and deputy QPPV for the EU supports the Global Pharmacovigilance (GPV) organization and the Qualified Person for Pharmacovigilance (QPPV) to maintain and advance the global PV system concerning procedure, training, audit/inspection, PV agreements/contracts, compliance management related tasks, and regulatory requirements (e.g. Pharmacovigilance System Master File (PSMF)) and communication. The Senior Global PV Policy, Regulation and Compliance manager and deputy QPPV (EU) coordinates or performs the activities within the department and is in contact with the described interfaces of other departments. By executing the tasks described, the Senior Global PV Policy, Regulation and Compliance manager and deputy QPPV (EU) is continuously challenging the existing processes and defined workflows and is seeking creative, new solutions to improve compliance, efficiency and effectiveness. Deputizes for the EU and UK QPPV, in its absence, for EU related QPPV responsibilities.

Your responsibilities:

Manage GPV procedures, training curricula, and onboarding/offboarding activities
Support Pharmacovigilance Agreements (PVAs) lifecycle management and compliance oversight
Coordinate GPV compliance reporting, metrics, and stakeholder communication
Support GPV audits, inspections, CAPA management, and PSMF maintenance
Act as a key interface between GPV, Quality, and external partners
Deputize for the EU/UK QPPV when required, including regulatory authority interactions and PV oversight
Provide strategic PV guidance and support benefit-risk monitoring activities
Contribute to continuous improvement and compliance initiatives across Global Pharmacovigilance

What You Need to Succeed (minimum qualifications):

Degree in Veterinary Medicine and at least 3-years experience in regulated industry, preferably in the area of pharmacovigilance
Knowledge of the processes and regulatory requirements in Veterinary Pharmacovigilance, particularly for the EU
Located in the EU
Good English language skills

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

Capable of working independently and making decisions autonomously
Compliance oriented with a strong quality mindset, capable of working under pressure and with short timelines
Ability to coordinate/ lead complex compliance related projects
Experience with interactions with competent authorities in the EU
Experience in participating in audits and authority inspections and follow-up activities
Experience in working effectively in teams and in a multi-cultural environment
Ability to comprehend interrelations and submit proposals for solutions.
Personal accountability and a strong drive for execution

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 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

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