PATIENT SAFETY SENIOR MANAGER

We’re building the future of medical dermatology by focusing on unmet patient needs and giving people the space to think independently, take ownership and make an impact that matters.

Our purpose is simple: to transform patients’ lives by addressing real needs. We work with care, act with courage, keep things simple and focus our innovation where it makes a difference.

Recognised as a Top Employer in Spain since 2008 and in Germany since 2025, we continue to invest in an environment where people can grow and move forward.

If you care differently, you belong here.

POSITION SUMMARY / MISSION

Responsible for the management of corporate pharmacovigilance activities in collaboration with internal and external stakeholders, ensuring the safety of Almirall’s marketed and investigational products. This role provides operational and medical support across clinical development and post-marketing safety surveillance, contributing to regulatory compliance and patient protection.

CORE RESPONSIBILITIES

• Provide operational and medical support to clinical trial activities, including SAE management, medical review, reconciliation, unblinding, and safety monitoring
• Lead the preparation and medical input for aggregate safety reports (e.g., DSURs) and other periodic regulatory submissions
• Review safety-related sections of clinical documentation, including protocol synopses, Data Management Plans, and Safety Topics of Interest
• Act as medical lead for the development of Safety Reporting Plans Participate actively in clinical study team meetings, both internally and with CROs Support non-interventional studies, market research, and registries, including ICSR management and safety monitoring
• Conduct post-marketing safety surveillance, including medical review and assessment of safety data Support the Patient Safety Director and EU QPPV in fulfilling internal and regulatory responsibilities Contribute to the Pharmacovigilance Quality Management System and ensure implementation of relevant procedures
• Perform tasks related to safety databases and signal detection (as medical writer or reviewer) Conduct review of PSURs and Risk Management Plans

REQUIRED EDUCATION AND EXPERIENCE

• Medical science degree and Postgraduate training in pharmacovigilance, clinical safety, or epidemiology are preferred.
• Experience in pharmacovigilance or clinical safety within a corporate setting is highly valued

PREFERRED SKILLS AND COMPETENCIES

• Proficiency in safety databases
• Strong understanding of Good Pharmacovigilance Practices (GVPs) and applicable regulatory frameworks