Senior Scientist - Aggregate Reporting

📋 Description

• Develop, review, and maintain high-quality safety and pharmacovigilance documents
• Synthesize data from ICSRs, aggregate safety data, clinical studies, epidemiological research
• Draft and support preparation of PSURs/PBRERs/PADERs, DSURs, signal assessment reports, aggregate
• Collaborate with Safety Scientists, Medical Reviewers, Drug Safety, Medical Affairs, Regulatory
• Support interpretation of safety trends, signals, and benefit-risk assessments
• Support literature surveillance and summarize safety findings

🎯 Requirements

• Advanced degree: PharmD, PhD, MD, MPH, MS, or equivalent scientific discipline
• 8-10 years of experience in pharmacovigilance, drug safety, medical writing, regulatory writing, or
• Experience preparing safety and pharmacovigilance documents preferred
• Familiarity with global pharmacovigilance regulations and safety reporting requirements
• Experience working in a matrixed environment with multiple stakeholders
• Strong understanding of clinical research methodologies, epidemiology, biostatistics