Pb Vetpharma /b is the veterinary division of Chemo, part of the Insud Pharma group, providing Animal Health solutions. We are located in Barcelona, where the group was founded in 1977. /pp In Vetpharma we are a highly qualified team. /pp We have extensive experience in development, registration and marketing veterinary medicinal products, API’s and nutraceuticals. /p pb Global Responsability: /b /p p We are seeking a highly experienced and dedicated Pharmacovigilance Manager to lead our veterinary drug safety function. The role is critical for ensuring the continuous monitoring, assessment, and management of adverse events, guaranteeing regulatory compliance and maintaining the highest standards of drug safety. /p pb Specific responsabilities /b /p olli Lead the Pharmacovigilance (PV) team, providing strategic direction, mentorship, and operational oversight. /lili Define the overall vision of the Pharmacovigilance system, coordinating to ensure b24/7 availability /b for safety reporting. /lili Ensure all adverse events reported are entered in the PV database in compliance with current legislation. /lili Assist in the establishment and maintenance of a system to collect, collate, and assess adverse event information related to the company’s marketed veterinary medicines, and ensure communication with b competent authorities /b. /lili Provide timely and comprehensive responses to requests from regulatory authorities regarding the company’s veterinary medicines. /lili Develop and maintain an up-to-date b Pharmacovigilance System Master File (PSMF) /b for veterinary medicines. /lili Ensure the availability of a local representative in every country where the company’s veterinary medicines are marketed, to receive adverse event reports. /lili Co-manage the existence and updating of PV agreements with local representatives and outsourced service providers. /lili Monitor that local representatives and external service providers comply with the current pharmacovigilance legislation and guidelines. /lili Continuously evaluate the benefit-risk profile of the company’s marketed veterinary products. /lili Ensure compliance with Good Pharmacovigilance Practices (GVP) or equivalent for veterinary medicines. /lili Assist other departments within the company in PV-related information requests. /lili Guarantee signal management, ensuring all required mechanisms are in place to fulfill responsibilities according to b Regulation (EU) 2019/6 /b. /lili Oversee the PV system and, when necessary, prepare and implement a suitable b Corrective and Preventive Action Plan (CAPA) /b. /lili Communicate any regulatory measure adopted in a third country related to PV data to the relevant competent authorities. /lili Report any change in the benefit-risk relationship or emerging risk to competent authorities / Agency within stipulated timelines, and take appropriate actions. /lili Implement and maintain an appropriate quality system for pharmacovigilance in accordance with applicable regulations. /li /ol pb Requirements: /b /pulli Bachelor’s degree in b Pharmacy, Chemistry, Veterinary Medicine /b, or a related life sciences disciplineMinimum of b3 years’ experience /b as a Qualified Person for Pharmacovigilance (QPPV) or equivalent safety leadership role. /lili Fluent in b English /b (written and spoken).. /lili Deep knowledge of pharmacovigilance regulations and guidelines, especially those relevant to b veterinary medicines /b (e.g., EU Regulation 2019/6). /lili Strong leadership and team management skills. /lili Experience with signal detection, benefit-risk evaluation, and quality systems (including CAPA). /lili Excellent communication skills and the ability to interact with regulatory authorities and local affiliates. /lili Highly organized, proactive, and able to work in a cross-functional global environment. /li /ul