Experteer Overview
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In this Medical Director, Patient Safety Physician role, you lead clinical safety across development and post-approval, partnering with cross-functional teams to turn safety evidence into decisive program actions. You shape safety strategies, risk management, and regulatory interactions to protect patients while enabling a diverse pipeline. Your work influences labeling, submissions, and safety standards, with a strong focus on impact, governance, and global safety systems. This is a science-led opportunity to drive patient well-being at scale within a collaborative culture.
Compensaciones / Beneficios
• Lead safety strategy for assigned products across development and post-launch
• Set safety go/no-go criteria and drive risk mitigation measures
• Develop and execute safety submission strategies; respond to regulatory questions
• Lead risk–benefit assessments and safety specifications
• Review and endorse risk management plans and pharmacovigilance activities
• Represent Patient Safety on clinical/project teams; chair Safety Management Teams
• Provide medical input for protocols, ICFs, investigator brochures, and study reports
• Oversee surveillance activities:



case review, signal detection, data sources, external provider collaboration
• Prepare labeling updates and safety information for integral reference safety data
• Contribute to periodic safety reports (PBRERs, PSURs, PADERs, DSURs) and integral submissions (NDA, BLA, MAA)
• Support QPPV role and pharmacovigilance system integrity; ensure inspection readiness
• Advise on licensing, regulatory meetings, and due diligence; support product liability discussions
• Lead process improvements using safety science, informatics, modeling, and simulation
• Mentor junior colleagues in signal evaluation, risk management, and xqbhyrx safety reporting
• Collaborate across functions and external partners to enhance safety data quality
Responsabilidades
• Medical degree (MD/MBBS) or equivalent
• At least 2 years of clinical experience post-registration
• Minimum 2 years in Drug Development and Patient Safety; proven delivery
• Strong medical competence aligned with industry standards and business goals
Requisitos principales
• in-person collaboration three days per week
• flexible working arrangement
• global impact on therapies
• ambitious, science-led culture
• opportunity for leadership development

📌 Medical Director, Patient Safety Physician (Barcelona)
🏢 AstraZeneca
📍 Barcelona