Senior Manager, PVRM Safety Scientist

About the role

Works closely with cross-functional colleagues, development teams and outside partners, and applies the company's safety governance processes to investigational and marketed products.

At a glance

What you will do

• Chair cross-functional safety management meetings and give safety input on protocols, consent forms, study reports and regulatory replies
• Run signal detection, evaluation and escalation through the established safety governance channels
• Keep safety profiles of assigned products under review and support benefit-risk assessment
• Review serious adverse event reports and clinical coding for consistency and quality
• Represent safety on joint partner forums and safety committee meetings as assigned

What they look for

• Experience in pharmacovigilance or drug safety within a pharmaceutical or biotech setting
• Familiarity with safety documents such as investigator brochures, protocols and clinical study reports
• Ability to work with clinical development, regulatory, biostatistics and data management colleagues
• Skill in aggregate safety analyses and responses to regulatory questions