Global Safety Lead – Formulation Safety

Overview

In this role you drive safety strategy for global formulation safety across development and post-approval phases. You collaborate with cross-functional teams to integrate safety risk management within medical, regulatory, and business contexts. You supervise safety surveillance, signal detection, and risk mitigation activities to protect patients and support regulatory expectations. Your leadership shapes the safety content of pivotal documents and ensures proactive resolution of safety issues in CSL Behring’s portfolio.

Responsibilities

• Oversee safety management teams reviewing clinical and post-marketing safety data
• Lead safety signal detection and medical signal evaluation processes
• Manage aggregate safety data analysis and preparation of DSURs, PSURs, and risk management plans
• Ensure timely production of aggregate safety reports and responses to Health Authorities
• Coordinate regulatory agency requests and address inspection findings with CAPA implementation
• Oversee development of safety content for clinical trial documents and core safety information for new products
• Set safety strategy for global projects and approve key filing documents (ISS, SCS, RMPs)
• Chair the Safety Management Team (SMT) and represent GSPV in cross-functional teams
• Provide guidance on medical, product, and process-related safety matters in a complex environment

Key requirements

• MD or international equivalent with accredited residency
• 2+ years as a physician in patient care
• 3+ years pharma/biotech industry experience with medical oversight or clinical development
• Therapeutic area experience in designated domains
• Proven ability to address complex medical issues in pre- and post-approval settings

• leadership and people management
• cross-functional collaboration
• strong communication and regulatory liaison skills
• pharmacovigilance and safety signal detection
• DSUR/PSUR and RMP preparation
• safety data analysis and safety risk management planning

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