Sr Director Global Safety Physician 

Key Responsibilities

• Provide expert safety guidance across all phases of development and post-market programs.

• Lead signal detection, risk assessment, and benefit-risk evaluation for assigned products.

• Oversee aggregate safety reporting (e.g., DSURs, PSURs), labeling, core safety documents, and risk management plans.

• Collaborate cross-functionally and with external partners to develop safety deliverables.

• Represent safety in regulatory interactions and support inspections/audits.

• Chair internal safety review teams and communicate safety trends to leadership.

Qualifications

• Medical degree with clinical background required.

• 7+ years in safety/pharmacovigilance, covering both development and marketed products.

• Strong track record in signal detection, safety data analysis, and global regulatory documentation.

• Experience in neurology or rare diseases is a plus.

• Familiar with MedDRA, ICH guidelines, and global safety regulations.

Skills & Attributes

• Skilled in interpreting complex clinical data.

• Strong communication and cross-functional collaboration.

• Ability to manage multiple priorities with attention to detail.

Experience with regulatory authority interactions preferred.

claude.morgan@mrlcg.com