Senior Manager, Data Management

Vetpharma; Madrid; Presencial; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

A leading veterinary pharmaceutical company in Madrid is seeking a Pharmacovigilance Manager to oversee drug safety functions and ensure compliance with regulations. Ideal candidates will have a Bachelor’s degree in a related field, at least 3 years of safety leadership experience, and strong communication skills. This role is critical for managing adverse events and requires leadership in a cross-functional environment.

Formación

• Minimum of 3 years’ experience as a Qualified Person for Pharmacovigilance (QPPV) or equivalent safety leadership role.
• Deep knowledge of pharmacovigilance regulations and guidelines relevant to veterinary medicines.
• Experience with signal detection, benefit-risk evaluation, and quality systems.

Responsabilidades

• Lead the Pharmacovigilance (PV) team and provide strategic direction.
• Define the overall vision of the Pharmacovigilance system.
• Ensure compliance with Good Pharmacovigilance Practices (GVP).
• Assist other departments with PV-related information requests.
• Communicate regulatory measures related to PV data.

Conocimientos

Fluent in English

Leadership skills

Communication skills

Organizational skills

Knowledge of pharmacovigilance regulations

Educación

Bachelor’s degree in Pharmacy, Chemistry, Veterinary Medicine, or related life sciences

Descripción del empleo

Vetpharma

is the veterinary division of Chemo, part of the Insud Pharma group, providing Animal Health solutions. 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 Responsibility

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.

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.
• 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.
• 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.
• Communicate any regulatory measure adopted in a third country related to PV data to the relevant competent authorities.
• Implement and maintain an appropriate quality system for pharmacovigilance in accordance with applicable regulations.

Qualifications

Bachelor’s degree in Pharmacy, Chemistry, Veterinary Medicine, or a related life sciences discipline.

Minimum 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., 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.