Farmacovigilanciaen Barcelona.
detalle oferta
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Amplía la información sobre el proceso contactando con:
Monica Cigarran Valea
ContactarCollaborate with the CSH in the maintenance of a pharmacovigilance system that ensures the registration of all safety information and the design, implementation, management and control of a risk-benefit safety strategy that meets the requirements established by Global Pharmacovigilance [GPV] and the Spanish Agency of Medicine and/or other official bodies regarding the assigned products that are authorized/marketed or in the investigation phase.
ver menosour client
Una de las farmacéuticas más importantes a nivel mundial busca un técnico experto en farmacovigilancia.
ver menosyour functions
Responsibilities and functions:
¿ Pharmacovigilance activities related to the assigned therapeutic area:
- Case management: Manage collection, processing, and submission to local HA of all ICSRs for all Sanofi products from all sources according to the defined timelines and quality parameters. Monitor the compliance for ICSRs and implement CAPAs as applicable.
- Periodic Safety Reports (PBRER): Analyse Periodic Safety Reports and their possible impact at the local level.
- Determine the regulatory action and, if appropriate, prepare the referral to health authorities.
- Analysis and validation of the safety information of the Technical Data Sheets, Package Leaflets, Instructions for Use, labelling, and Packaging Material containing safety information versus the reference documentation for submission by Registries to the Competent Authority (AEMPS, EMA, AESAN, etc.).
- Respond diligently to safety questions received in the PV department, from consumers, healthcare professionals, in coordination with the department's Country safety Manager.
- Knowledge and application of PV legislation.
- Collaborate with the Country Safety Manager and Country Safety Head in the management and sending of Safety Letters addressed to Healthcare Professionals.
- Collaborate with the Country Safety Manager and Country Safety Head in the identification and management of Product Alerts.
- Collaborate with the Country Safety Manager and Country Safety Head in the detection of signals.
position requisites
-
Formación
: Licenciado -
Idiomas
: Inglés: C2 -
Conocimientos
: farmacovigilancia -
Experiencia
: 1 año
Skills, experience and knowledge requirements
¿ Graduate in health sciences
¿ Previous work experience in pharmacovigilance
¿ Knowledge of the principles of pharmacovigilance
¿ Languages: High level of Spanish and English
¿ Good communication and presentation skills
¿ High teamwork spirit
¿ Organized and detail oriented
¿ Efficient time management
¿ Capacity to work under pressure, to prioritize activities, to identify and escalate issues as appropriate
your benefits
Salario muy competitivo
Contrato de sustitución maternidad
Inicio previsto: 1/05
Bonus según objetivos, cheques restaurante y un plus para cubrir el internet de tu casa
Alta Flexibilidad horaria
50% en casa 50% en oficina
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