Patient Safety Manager

Almirall Hermal GmbH; Madrid; Presencial; EUR 40.000 - 65.000; Jornada completa

Descripción de la vacante

A leading company in the pharmaceutical sector is seeking a professional for operational support in clinical trials and pharmacovigilance. The role involves managing safety reports, contributing to quality management systems, and collaborating with internal and external teams. Candidates should possess a relevant science degree and significant experience in pharmacovigilance.

Formación

• At least 5 years of pharmacovigilance experience.
• Experience in a corporate safety department preferred.

Responsabilidades

• Operational support for clinical trial activities.
• Management of aggregate reports and safety monitoring.
• Active participation in clinical study team meetings.

Conocimientos

Operational support

Safety monitoring

Data Management

Pharmacovigilance

Regulatory knowledge

Educación

Science Degree

Post-graduate training in pharmacovigilance

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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