Patient Safety Manager

Almirall Hermal GmbH; Torrejón de Ardoz; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A leading company in the pharmaceutical industry is seeking a Pharmacovigilance Specialist to provide operational support for clinical trials and post-marketing safety surveillance. The ideal candidate will have a Science Degree and at least 5 years of experience in pharmacovigilance. Responsibilities include managing safety reports, contributing to quality management systems, and supporting the Patient Safety Director. This role requires strong competencies in care, courage, innovation, and simplicity to enhance patient safety.

Formación

• At least 5 years of PV experience.
• Relevant post-graduate training in pharmacovigilance preferred.

Responsabilidades

• Operational support to clinical trial activities and safety monitoring.
• Management of Aggregate Reports and safety database tasks.
• Lead the creation of the Safety Reporting Plan.

Conocimientos

Listening

Empathizing

Valuing diversity

Challenging the status quo

Creating novel solutions

Educación

Science Degree

Herramientas

Safety databases

Descripción del empleo

Select how often (in days) to receive an alert :

Mission Tasks and Responsibilities

Mainly :

• Operational support to clinical trial activities including but not limited to SAE management, reconciliation, unblinding activities as well as support in safety monitoring activities during development.
• Management of Aggregate Reports (DSUR) and other periodic reports required by regulators to ensure data completeness by data lock, including providing tables and listings for these reports.
• Revision of the synopsis, safety sections of protocols, Data Management Plan, Safety Topics of Interest, and accountability for the RSI of the study.
• Lead the creation of the Safety Reporting Plan.
• Active participation in internal and CRO clinical study team meetings.
• Operational support to non-interventional studies, market research, registries, including ICSR management, reconciliation, and safety monitoring activities.
• Post-marketing safety surveillance activities.
• Support to the Patient Safety Director and EUQPPV in fulfilling internal duties and responsibilities towards authorities.
• Contribute to the Pharmacovigilance Quality Management System and implement necessary procedures per legislation.
• Perform safety database tasks as applicable.

Education

Science Degree. Relevant post-graduate training in pharmacovigilance, clinical safety, or epidemiology is preferred.

Specific Knowledge

Experience with safety databases, GVPs, and relevant regulations.

Experience

At least 5 years of PV experience. Experience in a corporate safety department is preferred.

Values and Competencies

• Care: Listening, empathizing, valuing diversity, and supporting each other's success.
• Courage: Challenging the status quo, taking ownership, and learning from successes and failures.
• Innovation: Centering on patient and customer needs, creating novel solutions, and fostering entrepreneurial mindsets.
• Simplicity: Acting decisively, understanding reasons before acting, being agile, and maintaining simplicity.

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