About the position We are sharing a specialised consulting opportunity for experienced Pharmacovigilance and Drug Safety professionals with strong expertise in DSURs, PSURs/PBRERs, aggregate safety analysis, signal management, benefit-risk assessment, MedDRA coding, and regulatory safety documentation to contribute to an advanced AI training and pharmacovigilance evaluation project. Selected professionals will review complex drug-safety materials, assess aggregate and case-level information, evaluate signal and benefit-risk conclusions, and provide structured feedback grounded in current pharmacovigilance standards. No prior experience in AI is required.

Responsibilities

• Review DSURs, PSURs/PBRERs, and related safety documentation for accuracy, completeness, and regulatory relevance
• Assess interval and cumulative safety information and associated case-level data
• Apply ICH E2F, ICH E2C(R2), and relevant GVP requirements
• Review report structure, appendices, and data presentation
• Identify issues affecting the defensibility of safety conclusions
• Evaluate emerging and established safety signals and supporting evidence
• Assess benefit-risk conclusions across development-stage and post-marketing settings
• Apply MedDRA coding principles and review seriousness, causality, and expectedness determinations
• Reconcile aggregate conclusions with underlying case information
• Identify unsupported assumptions, classification issues, or changes affecting the overall safety profile
• Reconcile case counts, figures, and safety data across reports and source materials
• Identify discrepancies between aggregate and case-level information
• Review AI-generated pharmacovigilance content for technical and regulatory accuracy
• Provide clear written rationales explaining evaluation decisions and identified deficiencies
• Support consistent quality standards across pharmacovigilance evaluation tasks

Requirements

• 5+ years of pharmacovigilance or drug-safety experience
• Experience at a sponsor, CRO, or as an independent consultant
• Demonstrated experience authoring or reviewing DSURs and/or PSURs/PBRERs end to end
• Strong working knowledge of ICH E2F, ICH E2C(R2), and relevant GVP guidance
• Experience with signal management and benefit-risk assessment
• Hands-on MedDRA coding experience
• Strong knowledge of seriousness, causality, and expectedness assessment
• Demonstrated ability to reconcile aggregate and case-level safety data
• Strong regulatory-documentation, analytical, and written communication skills
• No prior AI-training or model-evaluation experience is required

Nice-to-haves

• Advanced degree in life sciences, pharmacy, nursing, medicine, or a related discipline is highly valuable
• Development-stage and post-marketing safety experience is advantageous
• QPPV, deputy QPPV, or safety-committee experience is beneficial

Benefits

• Independent contractor engagement
• Fully remote
• Compensation: \$70–\$80/hour

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