Beschreibung

You will play a vital role in patient safety by providing pharmacovigilance expertise across the company's portfolio, from overseeing study management to leading complex risk assessments.

Anforderungen

• •Healthcare professional, Life Sciences graduate, or postgraduate qualification
• •Four years drug development experience and two years drug safety
• •Understanding of GxP and clinical trial lifecycle
• •Excellent written and verbal communication skills
• •Complex data analysis and statistical methods proficiency
• •Strong presentation and summarization skills
• •Ability to work independently and manage safety responsibilities

Aufgaben

• •Provide safety science and pharmacovigilance support
• •Influence early and late-phase development activities
• •Offer safety oversight for study management
• •Lead signal evaluation and benefit-risk assessments
• •Manage comprehensive safety risk activities
• •Oversee individual and aggregate case reporting
• •Prepare DSUR and PBRER aggregate reports
• •Drive signal detection and management processes
• •Maintain STAR and ISMP documentation
• •Contribute to the Clinical Development strategy
• •Prepare CCDS and labeling documents
• •Develop risk communications, RMP, and REMS
• •Identify personal and professional development areas

Tools & Technologien