Pharmacovigilance Manager

Vetpharma 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.

In Vetpharma we are a highly qualified team.

We have extensive experience in development, registration and marketing veterinary medicinal products, API’s and nutraceuticals.

Global Responsability :

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.

Specific responsabilities

• Lead the Pharmacovigilance (PV) team, providing strategic direction, mentorship, and operational oversight.
• Define the overall vision of the Pharmacovigilance system, coordinating to ensure 24 / 7 availability for safety reporting.
• Ensure all adverse events reported are entered in the PV database in compliance with current legislation.
• 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 competent authorities .
• Provide timely and comprehensive responses to requests from regulatory authorities regarding the company’s veterinary medicines.
• Develop and maintain an up-to-date Pharmacovigilance System Master File (PSMF) for veterinary medicines.
• Ensure the availability of a local representative in every country where the company’s veterinary medicines are marketed, to receive adverse event reports.
• Co-manage the existence and updating of PV agreements with local representatives and outsourced service providers.
• Monitor that local representatives and external service providers comply with the current pharmacovigilance legislation and guidelines.
• Continuously evaluate the benefit-risk profile of the company’s marketed veterinary products.
• Ensure compliance with Good Pharmacovigilance Practices (GVP) or equivalent for veterinary medicines.
• Assist other departments within the company in PV-related information requests.
• Guarantee signal management, ensuring all required mechanisms are in place to fulfill responsibilities according to Regulation (EU) 2019 / 6 .
• Oversee the PV system and, when necessary, prepare and implement a suitable Corrective and Preventive Action Plan (CAPA) .
• Communicate any regulatory measure adopted in a third country related to PV data to the relevant competent authorities.
• Report any change in the benefit-risk relationship or emerging risk to competent authorities / Agency within stipulated timelines, and take appropriate actions.
• Implement and maintain an appropriate quality system for pharmacovigilance in accordance with applicable regulations.

Requirements :