Global Formulation Safety Leader

CSL; Waltham (MA); On-site; USD 250,000 - 385,000; Full time

Job summary

CSL seeks a Director, Global Safety Lead, Formulation Safety to oversee safety across the product lifecycle from clinical development through post-approval. Apply medical judgment to complex safety data, support signal detection, and drive risk management activities, including safety specifications, PV planning, and mitigation strategies.

The role leads cross-functional development teams, sets global safety strategy, and ensures compliance with safety objectives for CSLB projects, interacting

Qualifications

• MD with physician licensure and clinical experience.
• Experience leading pharmacovigilance activities across development and post-approval.
• Strong knowledge of safety risk management and regulatory expectations.
• Ability to lead cross-functional teams in a complex medical environment.

Responsibilities

• Oversee safety surveillance and risk management for CSLB portfolio.
• Ensure quality management and timely responses to health authorities.
• Lead safety strategy and representation in cross-functional teams.
• Chairs the Safety Management Team and represents GSPV in relevant projects.

Skills

MD

Clinical development

Safety signal detection

Regulatory communication

Leadership

Education

MD or international equivalent

Job description

CSL seeks a Director, Global Safety Lead, Formulation Safety to oversee safety across the product lifecycle from clinical development through post-approval. Apply medical judgment to complex safety data, support signal detection, and drive risk management activities, including safety specifications, PV planning, and mitigation strategies.

The role leads cross-functional development teams, sets global safety strategy, and ensures compliance with safety objectives for CSLB projects, interacting