PHARMACOVILIGANCE DIRECTOR
hace 13 días
Mataró
Get AI-powered advice on this job and more exclusive features. Habilidades, experiencia, cualificaciones... Si tiene el perfil adecuado para esta oportunidad, asegúrese de inscribirse hoy mismo. 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, • In combination with top management, Define and implement the company’s pharmacovigilance strategy., • Represent PV in internal and client meetings., • Operational Oversight, • Supervise QPPV office, scientific literature screening, case processing, aggregate reporting, and risk management activities., • Ensure compliance with applicable regulations., • Oversee all other safety activities and quality control., • Client & Project Management, • Ensure timely delivery of safety deliverables (e.g., PSURs, DSURs, RMPs)., • Support business development through proposals and client presentations., • Regulatory Compliance, • Prepare for and lead audits and inspections., • Ensure SOPs and processes align with current regulatory expectations., • Manage safety exchange agreements and vendor oversight., • Lead and mentor a team of PV professionals., • Oversee training, performance reviews, and career development., • 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. xcskxlj, • The possibility to lead a competitive and challenging team. Seniority level Director Employment type Full-time Industries Human Resources Services #J-18808-Ljbffr