Position SummaryThe Medical Safety Director, Clinical Scientist provides clinical science support to product activities, ensuring high-quality clinical input into routine maintenance documentation, safety and labeling deliverables, and issue resolution activities.This role partners closely with cross-functional product teams, represents Clinical Science in key governance forums, and provides expert clinical review and recommendations to support product benefit-risk evaluation, regulatory compliance, and labeling consistency. The position works in close collaboration with the General Clinical Science Lead, escalating critical issues and contributing to timely, scientifically robust decision-making.Key responsibilitiesParticipate in relevant product-team meetings including Labelling Working Group (LWG)as the Clinical Science representativeGather and provide necessary information under guidance from the GCLReview draft documents (PBRER/PSUR, CCDS/CCSI, US Annual Report)



from a Clinical Science perspective; share key points and any critical issues with the GCLParticipate in relevant Safety Management Team (SMT) meetings as the Clinical Science representativeReview Safety Validation and Evaluation Report draft documents; share key points and any critical issues with the GCL etc.Required ExperienceMD, PharmD, PhD, or equivalent advanced life sciences degree with strong clinical science expertise and the ability to interpret clinical, safety, and scientific literature within a benefit-risk framework.Proven experience supporting regulatory and pharmacovigilance deliverables, including PBRER/PSUR, CCDS/CCSI, US Annual Reports, and Safety Evaluation Reports.Hands-on experience reviewing and contributing to clinical sections of safety, regulatory, and labeling documents, ensuring scientific accuracy, consistency, and compliance.Strong knowledge of drug safety, pharmacovigilance, risk management, and global labeling processes within the pharmaceutical industry.Experience partici

📌 Medical Safety Director, Clinical Scientist (Barcelona)
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📍 Barcelona