Requirements & Experience:

• Lead preparation of PSUR, PBRER, and DSUR reports
• Oversee data collection from PV, clinical, and medical teams
• Ensure compliance with FDA, EMA, and ICH guidelines
• Manage timelines, review cycles, and submissions
• Review safety data analyses and benefitrisk sections
• Coordinate internal and external reviewers
• Maintain version control and audit-ready documentation
• Respond to regulatory authority queries
• Mentor junior PV writers and reviewers
• Drive continuous improvement in aggregate reporting processes