**Date**:30 Oct 2024
**Location**: SFEL - R&D; SANT FELIU DE LLOBR, ES, ES - Spain
**Company**:Almirall
**Mission**:
Patient safety. Management of corporate pharmacovigilance activities in collaboration with different internal and external stakeholders to ensure the overall success of the business and the safety of the assigned Almirall marketed or investigational products, providing strategic oversight in a designated functional area (e.g., training, compliance, resource and quality management).
**Tasks and Responsibilities**:
Safety Data Management - amongst others: support reconciliations, assist with PSMF updates, collaborate with stakeholders for new solutions (with guidance).
Integral Safety Database Maintenance: contribute to upgrades, ensure quality, acts a contact point for all safety database users, keep specific trackers, assist in ongoing safety surveillance by providing listings and reports, support the set-up and maintenance of electronic exchange of cases.
Quality Management System (QMS) tasks
Innovation and Technology Evaluation
- Learn about new technologies, including AI, for handling safety cases, processing data, signaling potential issues, creating reports, and analyzing information.
- Support the evaluation of vendor products and propose enhancements, with guidance.
- Facilitate the change management, development, testing strategy, implementation, deployment strategy, and hyper care support for new solutions and for ongoing technical enhancements of existing solutions, under supervision
**Education**:
- Science degree and/or master’s degree and/or some experience in related filed, such as internships or part-time roles in clinical research, regulatory affairs or pharmacovigilance. _
**Skills**:
English and Spanish professional fluency required.
Familiarity with databases, data entry, and basic data analysis tools.
Attention to the detail and analytical skills to analyze data and identify trends or issues
Communication skills, both written and verbal, to effectively communicate with cross-functional teams.
Willingness to work collaboratively in a team environment.
- Desirable:_ Understanding of pharmacovigilance principles, drug safety regulations, and clinical trial processes