08 oct
|
Richard Lombart Consulting & The Executive Way
|
Barcelona
08 oct
Richard Lombart Consulting & The Executive Way
Barcelona
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 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: Univ
📌 PHARMACOVILIGANCE DIRECTOR (Barcelona)
🏢 Richard Lombart Consulting & The Executive Way
📍 Barcelona