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Categoría: Oferta de empleo

Descripción: Empresa de selección de directivos , en la actualidad cubriendo varias posiciones para la industria farmaceutica desea cubrir el puesto de DRUG SAFETY QUALITY ASSURANCE PHARMACOVIGILANCE. Se requiere Grado en biosanitario con estudios de postgrado en farmacovigilancia y calidad preferiblemente.


Fecha Inicio: 19-10-2017

Fecha Fin: 19-11-2017

Más Información: Under the supervision of the QPPV and in cooperation with the Quality Department performs quality assessment of all Pharmacovigilance activities by: - Measuring compliance to process, process effectiveness and data quality. - KPI management and monitoring. - Identifying procedural gaps, proposing and implementing process improvement measures as needed. - Periodic monitoring and updating of pharmacovigilance documents (such as Safety Data Exchange Agreements with partners and ICSR reconciliations with partners). - Detecting processes at risk requiring further quality assessments in Pharmacovigilance. - Proposing Corrective Action Plan Activities (CAPA) and participating in their implementation. - Oversee all interactions during inspections/external audits including provision of documentation, briefing/debriefing with inspection/audit teams, and coordination of inspection/audits responses and follow-up activities. - Generation, revision and updating of all pharmacovigilance SOPs. - Performing relevant training to staff on audit/inspection, CAPA handling and Good Pharmacovigilance Practices. Education and working experience - Certified health professional degree required. - Minimum experience of 3 years in Pharmacovigilance activities and in quality assessment in PV. Skills - Demonstrated understanding of the key Pharmacovigilance processes. - Knowledge of international regulations and guidelines ICH, CIOMS, EMA/FDA - Experience in quality management: audit, inspections, corrective action plan (CAPA methodology) definition and implementation, KPIs. - Ability to identify gap in quality issue. - Ability to work independently. - Strong interpersonal skills: interaction with individuals of various background such as various levels in other departments and other partners. - Very good level of English. - Good knowledge of French is a plus. - Familiar with the use of a safety database (familiar with PcVManger is a plus).

Lugar del evento: Madrid

Convocante: Servicio de Prácticas y Orientación Profesional