Get AI-powered advice on this job and more exclusive features. Our client is a company operating in the pharmaceutical business engaged in providing services to the industry peers, especially qualified and experienced in Business Development, Pharmacovigilance, Regulatory Affairs, GxP Compliance. The core business is:
* Identify the best business partners.
* Identify the best product/source fit.
* Ensure European Pharmacovigilance Compliance.
* Meet the European GMP/GDP standards. Prepare, submit and/or maintain Marketing Authorisations in Europe. DUE. ITS GROWTH, they need to cover an : PHARMACOVIGILANCE DIRECTOR The Pharmacovigilance (PV) Director is a senior leadership role responsible for overseeing all drug safety and pharmacovigilance operations. In a services company, this includes managing client relationships, ensuring regulatory compliance, leading safety teams, and delivering high-quality PV services across multiple projects and sponsors.

Key Responsibilities
* Strategic Leadership Asegúrese de enviar su solicitud rápidamente para maximizar sus posibilidades de ser considerado para una entrevista. Lea la descripción completa del puesto a continuación. o In combination with top management, Define and implement the company's pharmacovigilance strategy. o Represent PV in internal and client meetings.
* Operational Oversight o Supervise QPPV office, scientific literature screening, case processing,



aggregate reporting, and risk management activities. o Ensure compliance with applicable regulations. o Oversee all other safety activities and quality control.
* Client & Project Management o Ensure timely delivery of safety deliverables (e.g., PSURs, DSURs, RMPs). o Support business development through proposals and client presentations.
* Regulatory Compliance o Prepare for and lead audits and inspections. o Ensure SOPs and processes align with current regulatory expectations. o Manage safety exchange agreements and vendor oversight. o Lead and mentor a team of PV professionals. o Oversee training, performance reviews, and career development. o Forecast staffing needs and manage resource allocation. Qualifications
*

Education:
University degree in Medicine, Pharmacy or Life Sciences.
*

Experience:
+10 years in pharmacovigilance, with at least 5 years in a leadership role.
* Industry: Experience in PV services environment is highly preferred.
* Languages: Fluent in English and Spanish. Benefits
* Excellent salary package, according the experience.
* Hybrid model work (2 days at work, 3 days at home), with flexibility, not mandatory. xohynlm
* The possibility to lead a competitive and challenging team. Seniority level Director Employment type Full-time Industries Human Resources Services

📌 Director de Regulatory Affairs (Barcelona)
🏢 Richard Lombart Consulting & The Executive Way
📍 Barcelona