Pharmacovigilance Manager

hace 7 días

Barcelona, Barcelona, España Vetpharma A tiempo completo

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

  1. Lead the Pharmacovigilance (PV) team, providing strategic direction, mentorship, and operational oversight.
  2. Define the overall vision of the Pharmacovigilance system, coordinating to ensure
    24/7 availability
    for safety reporting.
  3. Ensure all adverse events reported are entered in the PV database in compliance with current legislation.
  4. 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
    .
  5. Provide timely and comprehensive responses to requests from regulatory authorities regarding the company's veterinary medicines.
  6. Develop and maintain an up-to-date
    Pharmacovigilance System Master File (PSMF)
    for veterinary medicines.
  7. Ensure the availability of a local representative in every country where the company's veterinary medicines are marketed, to receive adverse event reports.
  8. Co-manage the existence and updating of PV agreements with local representatives and outsourced service providers.
  9. Monitor that local representatives and external service providers comply with the current pharmacovigilance legislation and guidelines.
  10. Continuously evaluate the benefit-risk profile of the company's marketed veterinary products.
  11. Ensure compliance with Good Pharmacovigilance Practices (GVP) or equivalent for veterinary medicines.
  12. Assist other departments within the company in PV-related information requests.
  13. Guarantee signal management, ensuring all required mechanisms are in place to fulfill responsibilities according to
    Regulation (EU) 2019/6
    .
  14. Oversee the PV system and, when necessary, prepare and implement a suitable
    Corrective and Preventive Action Plan (CAPA)
    .
  15. Communicate any regulatory measure adopted in a third country related to PV data to the relevant competent authorities.
  16. Report any change in the benefit-risk relationship or emerging risk to competent authorities / Agency within stipulated timelines, and take appropriate actions.
  17. Implement and maintain an appropriate quality system for pharmacovigilance in accordance with applicable regulations.

Requirements:

  • Bachelor's degree in
    Pharmacy, Chemistry, Veterinary Medicine
    , or a related life sciences disciplineMinimum of
    3 years' experience
    as a Qualified Person for Pharmacovigilance (QPPV) or equivalent safety leadership role.
  • Fluent in
    English
    (written and spoken)..
  • Deep knowledge of pharmacovigilance regulations and guidelines, especially those relevant to
    veterinary medicines
    (e.g., EU Regulation 2019/6).
  • Strong leadership and team management skills.
  • Experience with signal detection, benefit-risk evaluation, and quality systems (including CAPA).
  • Excellent communication skills and the ability to interact with regulatory authorities and local affiliates.
  • Highly organized, proactive, and able to work in a cross-functional global environment.

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