Oferta de empleo

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Oferta publicada el 15 de Noviembre

Clinical Safety Specialist

Esta oferta ha recibido 40 visitas

Madrid, España

Vacantes: 1

Empresa que publica la oferta: QualitecFarma

qualitec2

Descripción de la oferta

Descripción:

Clinical Pharmacovigilance expert in direct report to the Global Pharmacovigilance Manager. To manage and coordinate the safety of Clinical Trials.

• Direct collaboration with clients and other vendors to determin safety workflow during clinical trials

• Act as primary responsible for clinical safety activities in the company: coordinate projects, train staff, design project specific procedures (as contracted) and communicate directly with clients/sponsors

• Process serious adverse events (SAEs) according to QualitecFarma's Standard Operating Procedures (SOPs) and project specific safety plans

• Receive SAE forms from investigator sites, evaluate SAEs for completeness and accuracy, perform data entry into internal database, coding of SAEs, develop narratives and perform quality check before case lock

• Write and submit regulatory documents necessary in clinical trials such as DSURs

• Write Safety Management Plans to optimize safety workflow in Clinical Trials

• Prepare and submit SUSARs to all relevant parties (Competent Authorities, Ethics Committees and investigators) within applicable timelines

• Participate in pharmacovigilance training, internal and external as required by clients

• Report all activities performed to sponsors as contracted

• Develop continuously new process implementations and improvements

Tipo de contrato:

Indefinido

REMUNERACIÓN / AÑO:

According to candidate skills.

VENTAJAS SOCIALES / ECONÓMICAS:

To be defined according to candidate skills and experience.

Requisitos de la oferta

Requisitos:

• University degree in life-science, pharmacy or equivalent related area/education.

• High level of fluent English is mandatory

• Strong knowledge in Pharmacovigilance

• Ability to work with high degree of independence

• Ability to manage multiple projects simultaneously

• Effective communication, written and oral

• Problem solving and negotiation skills

• Ability to manage multiple tasks with deadlines

NIVEL MÍNIMO DE ESTUDIOS:

Licenciatura

EXPERIENCIA PROFESIONAL MÍNIMA:

3 años

DISPONIBILIDAD PARA VIAJAR:

¿Como se inscriben los candidatos?

Interesados/as deberán enviar su CV a eugenia.diaz@qualitecfarma.com

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