Global Pharmacovigilance: Signal Manager

Role Description

We are seeking a veterinary professional with strong global regulatory expertise to join our Global Pharmacovigilance team, ensuring rigorous post-marketing surveillance of veterinary medicinal products in compliance with evolving regulatory requirements worldwide. This role requires a deep understanding of clinical veterinary medicine, pharmacovigilance science, epidemiology, and regulatory affairs, with a particular emphasis on the implementation and adherence to key regulations such as the EU Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6, effective January 2022), UK Benefit-Risk Submission Report (BRSR), as well as regulatory frameworks across North America, Asia-Pacific, Latin America, and other regions. The successful candidate will lead signal detection and management activities, contribute to global regulatory submissions, and drive continuous improvement within a complex, multinational regulatory environment.

Key Responsibilities

• Lead comprehensive post-marketing surveillance activities including proactive monitoring, adverse event trend analysis, signal detection, and signal management for assigned veterinary products, ensuring compliance with global regulatory standards.
• Perform detailed risk assessments and provide scientifically and regulatorily sound recommendations to mitigate safety risks impacting animal health.
• Serve as the pharmacovigilance and regulatory affairs expert within cross-functional global teams, ensuring integration of safety data and regulatory intelligence into product lifecycle management and decision-making.
• Author and review regulatory submissions and communications.
• Maintain and manage technical safety documentation within the global signal management system, ensuring data integrity, traceability, and compliance with worldwide regulatory expectations.
• Utilize advanced pharmacovigilance software and data analytics tools to interpret safety data and enhance signal detection methodologies, ensuring alignment with global regulatory frameworks.
• Lead initiatives to innovate and optimize signal detection and management processes, incorporating emerging scientific, technological, and regulatory developments from a global perspective.
• Champion change management and continuous improvement efforts to optimize pharmacovigilance workflows and tools, promote regulatory compliance, and enhance data quality worldwide.
• Advocate for and guide the adoption of new technologies and digital tools that improve operational efficiency, data accuracy, and regulatory adherence across multiple regions.
• Provide training and mentorship on pharmacovigilance systems, global regulatory requirements, and best practices, with a focus on the latest international regulations and guidelines.
• Support regulatory inspections, audits, and internal reviews by providing expert pharmacovigilance and regulatory affairs input, particularly related to compliance with the 2022 EU regulations and other global standards.
• Lead sub-teams to critically evaluate pharmacovigilance processes, identify compliance gaps, and implement effective corrective and preventive actions on a global scale.

Qualifications

• Doctor of Veterinary Medicine (DVM) or advanced degree in a relevant biomedical or animal health discipline.
• Minimum of 3 years' clinical veterinary experience or equivalent in animal health industry settings.
• Proven expertise in veterinary pharmacovigilance with a strong regulatory affairs focus, including signal detection, data analytics, epidemiology, and regulatory submissions.
• In-depth knowledge of global veterinary pharmacovigilance regulations, including but not limited to the EU Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6), UK Benefit-Risk Submission Report (BRSR) Guidance, as well as regulatory frameworks in North America, Asia-Pacific, Latin America, and other key markets.
• Demonstrated experience preparing and interpreting regulatory submissions and managing compliance within a highly regulated, multinational environment.
• Proven ability to lead change management and continuous improvement initiatives in pharmacovigilance and regulatory affairs.
• Experience with digital transformation and adoption of innovative technologies in pharmacovigilance or related fields.
• Strong scientific and regulatory communication skills, with the ability to articulate complex safety and regulatory information clearly and accurately to diverse global audiences.
• Excellent organizational skills and proven ability to collaborate effectively within multidisciplinary and cross-functional global teams.
  

About Zoetis

At Zoetis, our purpose is to nurture the world and humankind by advancing care for animals. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock. We know our people drive our success. Our award-winning culture, built around our Core Beliefs, focuses on our colleagues' careers, connection and support. We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.

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