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.
Key Responsibilities
Aggregate Safety & Regulatory Review
- 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
Signal, Benefit-Risk & Case Assessment
- 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
Data Quality & AI Evaluation
- 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
Ideal Profile
- 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
- 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
- No prior AI-training or model-evaluation experience is required
Engagement Details
- Independent contractor engagement
- Fully remote
- Compensation: $70–$80/hour
- Work will involve DSUR and PSUR/PBRER review, aggregate safety analysis, signal management, benefit-risk assessment, MedDRA coding, case-level review, data reconciliation, and regulatory documentation
- Assignments may involve development-stage and post-marketing safety materials, aggregate reports, case records, regulatory documentation, and AI-generated safety analyses
- Project scope, workload, safety topics, and evaluation standards may evolve depending on project requirements
- Work must be completed without using confidential, proprietary, or identifiable patient information belonging to any employer, sponsor, CRO, healthcare organisation, research institution, patient, or other third party
About the Platform
This opportunity is available through 24-MAG LLC. We connect experienced professionals with remote consulting opportunities across technical, evaluation, and project-based workstreams.
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