Medical Safety Specialist

Medical Safety Specialist responsible for the drug surveillance program, including follow-up, risk assessment, and relatedness to product on adverse reaction reports, and safety oversight in clinical trials and post-marketing programs. Provides safety support to regulatory and clinical documents, conducts literature reviews, signal detection, and safety input for regulatory inquiries; assists with Health Authority assessments and responses; acts as SME for Medical Operations/Medical Function and leads training and mentoring of junior staff. Develops safety deliverables, maintains safety processes, and supports new indication submissions where applicable. Works within a flexible, collaborative, and inclusive culture with emphasis on regulatory compliance and risk management across the product lifecycle.