Pharmacovigilance Expert

micro1 is seeking experienced Pharmacovigilance Experts to contribute their advanced drug safety knowledge to a key project focused on training next-generation AI systems. In this role, you will apply your domain expertise to shape how models learn and reason, ensuring high-quality, real-world input for AI-driven pharmacovigilance tools.

Key responsibilities

• Author and review evaluation tasks based on DSURs, PSURs/PBRERs, and associated safety data and case-level records.
• Apply expert judgment to assess the accuracy of interval safety findings, signal evaluations, and benefit-risk conclusions.
• Assess template and structural conformity to ICH E2F and ICH E2C requirements, ensuring completeness and regulatory alignment.
• Reconcile figures and case counts across report sections and data sources to identify discrepancies.
• Deliver structured feedback to inform the development of AI-driven tools for pharmacovigilance documentation and analysis.

Requirements

• 5+ years of pharmacovigilance or drug safety experience at a sponsor, CRO, or as an independent consultant.
• Demonstrated proficiency in authoring or reviewing DSURs and/or PSURs/PBRERs from start to finish.
• Working fluency with ICH E2F, ICH E2C(R2), and GVP guidelines, including signal management and benefit-risk assessment.
• Hands-on experience with MedDRA coding, seriousness and causality assessment, and aggregate safety data analysis.
• Advanced degree in life sciences, pharmacy, nursing, or medicine (PharmD, MD, MSc, or equivalent).

What we offer

• Opportunity to influence the development of cutting-edge AI technology in the pharmaceutical sector.
• Fully remote work environment allowing for flexible professional engagement.
• Collaboration on high-impact projects requiring deep domain expertise.