PATIENT SAFETY SENIOR MANAGER
almirall · SANT FELIU DE LLOBREGAT ·
- Seniority
- Senior
- Category
- Healthcare
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.
Help shape the future of patient safety.
At Almirall, we are committed to improving the lives of patients through science, innovation, and care. We are looking for a medical safety professional who is passionate about protecting patients and ensuring the highest standards of pharmacovigilance across our investigational and marketed products.
In this role, you will work at the intersection of clinical development, post-marketing surveillance, and regulatory compliance, collaborating with global cross-functional teams to ensure that patient safety remains at the heart of everything we do.
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