Global Pharmacovigilance – Signal Manager

Job Description: • 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. Requirements: • 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. Benefits: • healthcare • dental coverage • retirement savings benefits • paid holidays • vacation • disability insurance Apply tot his job