Overview In this role you safeguard patient safety by coordinating pharmacovigilance across clinical development and post-marketing activities. You will collaborate with integral teams to ensure regulatory compliance and robust safety monitoring. You provide operational and medical input for trials, safety reports, and submissions, while leading safety planning and medical reviews. Your work drives risk assessment and data-driven decisions to protect patients and support product safety strategy.

Responsabilidades

Provide operational and medical support to clinical trials, including SAE management, medical review, reconciliation, unblinding, and safety monitoring

Lead preparation and medical input for aggregate safety reports (DSURs) and periodic regulatory submissions

Review safety-related sections of clinical documents (protocol synopses, Data Management Plans, Safety Topics of Interest)

Act as medical lead for the development of Safety Reporting Plans

Participate in clinical study team meetings, including CRO collaboration

Support non-interventional studies, market research,



and registries (ICSR management and safety monitoring)

Conduct post-marketing safety surveillance, including medical review of data

Support the Patient Safety Director and EU QPPV in regulatory duties

Contribute to Pharmacovigilance Quality Management System and implementation of procedures

Perform safety database tasks and signal detection as medical writer or reviewer

Review PSURs and Risk Management Plans

Requisitos principales Medical science degree

Postgraduate training in pharmacovigilance, clinical safety, or epidemiology (preferred)

Experience in pharmacovigilance or clinical safety in a corporate setting (valued)

Proficiency in safety databases

Strong understanding of GVPs and regulatory frameworks

Cross-functional collaboration

Attention to detail

Effective communication with internal teams and CROs

Safety databases proficiency

ICSR management

DSUR and PSUR review

📌 PATIENT SAFETY SENIOR MANAGER (Barcelona)
🏢 Almirall
📍 Barcelona