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

Elanco Animal Health Incorporated; Sweden; Presencial; SEK 1.000.000 - 1.400.000; Jornada completa

Descripción de la vacante

Elanco Animal Health Incorporated, a global leader in animal health, is seeking a Senior Global PV Policy, Regulation and Compliance Manager with EU deputising for the QPPV. The role focuses on maintaining and improving the pharmacovigilance system, training, audits, and regulatory compliance across EU activities.

Key tasks include managing GPV procedures, PVA lifecycle, compliance reporting, and coordinating with Quality and external partners.

Formación

• Degree in Veterinary Medicine is required.
• Minimum 3 years in a regulated industry, preferably pharmacovigilance.
• Good English language skills and EU location are required.

Responsabilidades

• Manage GPV procedures, training curricula, and onboarding/offboarding activities.
• Support GPV agreements lifecycle management and compliance oversight.
• Coordinate GPV compliance reporting, metrics, and stakeholder communication.
• Support GPV audits, inspections, CAPA management, and PSMF maintenance.
• Act as an interface between GPV, Quality, and external partners.
• Deputize for EU/UK QPPV when required and liaise with authorities.
• Provide strategic PV guidance and support benefit-risk monitoring.

Educación

Degree in Veterinary Medicine

Descripción del empleo

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

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.

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job-related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.