Job Description
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.
Full time
Regular
Colleague
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Job Tags
Full time, Local area, Worldwide,