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... For full info follow application link.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at [email protected] to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
