Patient Safety Manager

Almirall Hermal GmbH; Málaga; Presencial; EUR 45.000 - 60.000; Jornada completa

Descripción de la vacante

A leading company in the pharmaceutical sector seeks a skilled professional to support clinical trial activities and ensure compliance with safety regulations. The role involves operational support, report management, and collaboration with internal teams. Ideal candidates will have extensive experience in pharmacovigilance and a strong educational background in science.

Formación

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

Responsabilidades

• Operational support to clinical trial activities including SAE management.
• Management of Aggregate Reports and ensuring data completeness.
• Lead the creation of the Safety Reporting Plan.

Conocimientos

Pharmacovigilance

Clinical Safety

Data Management

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 :

1. Operational support to clinical trial activities including but not limited to SAE management, reconciliation, unblinding activities, and support in safety monitoring activities during development.
2. 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.
3. Revision of the synopsis, safety sections of protocols, Data Management Plan, Safety Topics of Interest, and accountability for the RSI of the study.
4. Lead the creation of the Safety Reporting Plan.
5. Active participation in internal and CRO clinical study team meetings.
6. Operational support to non-interventional studies, market research, registries, including ICSR management, reconciliation, and safety monitoring activities.
7. Post-marketing safety surveillance activities.
8. Support to the Patient Safety Director and EUQPPV in fulfilling internal duties and responsibilities towards authorities.
9. Contribute to the Pharmacovigilance Quality Management System and implement necessary procedures per legislation.
10. 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.