Patient Safety Manager

Almirall Hermal GmbH; España; Presencial; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

An established industry player is seeking a skilled Pharmacovigilance Specialist to provide operational support for clinical trials and ensure compliance with safety regulations. This role involves managing safety databases, preparing Aggregate Reports, and contributing to the Pharmacovigilance Quality Management System. The ideal candidate will have at least 5 years of experience in pharmacovigilance and a strong background in clinical safety. Join a dynamic team focused on innovation and patient safety, where your expertise will directly impact the quality of healthcare solutions.

Formación

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

Responsabilidades

• Operational support to clinical trial activities and safety monitoring.
• Management of Aggregate Reports and ensuring data completeness.
• Contribute to the Pharmacovigilance Quality Management System.

Conocimientos

Pharmacovigilance

Clinical Safety

Data Management

SAE Management

Regulatory Compliance

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.