Patient Safety Physician or Medical Reviewer || WFH

About the role

You will contribute to signal detection, medical review, and benefit-risk assessments for pharmaceutical products. Working in a dynamic, global environment, you will collaborate with multidisciplinary teams to ensure regulatory compliance and support safety-related decision-making. Your expertise will help shape risk mitigation strategies and maintain the integrity of product safety profiles.

What you'll do

• Perform medical reviews and assessments of Individual Case Safety Reports (ICSRs), including seriousness, causality, expectedness, and clinical relevance
• Conduct signal detection and evaluation using pharmacovigilance databases and statistical tools, including disproportionality analysis
• Analyze aggregate safety data from clinical trials, post-marketing surveillance, and scientific literature to identify emerging safety trends
• Contribute to the preparation and review of Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs)
• Participate in signal management activities, including signal validation, prioritization, documentation, and escalation

What you need

• Pharmacovigilance
• Clinical research
• Documentation
• Communication
• SOP writing
• Safety management

Good to have

• Pharmacology