We are sharing a specialised part-time consulting opportunity for experienced medical safety and drug safety professionals with substantial expertise in aggregate safety reporting, clinical safety data, benefit-risk assessment, and signal evaluation.
This role supports advanced research workflows involving the generation and validation of clinical safety data and the development of complex safety-reporting deliverables. Selected experts will work across adverse-event data, patient narratives, DSUR and PBRER reporting, signal interpretation, and structured task development grounded in real-world medical safety practice.
Key Responsibilities
Clinical Safety Data Generation & Review
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Generate and validate safety-focused clinical datasets
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Review adverse event and serious adverse event records for accuracy, consistency, and completeness
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Assess discontinuations, protocol deviations, and related safety information
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Determine whether safety conclusions are supported by the underlying patient and study data
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Identify missing, inconsistent, or clinically implausible information
Adverse Event & SAE Assessment
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Review adverse events and serious adverse events across clinical development programmes
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Assess seriousness, severity, expectedness, timing, and clinical context
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Evaluate causality assessments and supporting evidence
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Distinguish investigator causality from sponsor causality where relevant
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Identify cases requiring deeper review or additional clarification
Patient Narratives & Fatal-Case Review
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Develop and review detailed clinical safety narratives
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Assess chronology, medical history, concomitant treatment, exposure, and outcomes
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Ensure narratives accurately reflect the available safety data
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Perform comprehensive review of complex and fatal cases
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Identify unsupported conclusions, missing evidence, and inconsistencies in case interpretation
DSUR & PBRER Authoring
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Author complete Development Safety Update Reports (DSURs) and component sections
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Develop complete Periodic Benefit-Risk Evaluation Reports (PBRERs) and related content
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Integrate cumulative safety information across reporting periods
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Evaluate emerging safety findings against overall product exposure
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Maintain consistency across analyses, narratives, tables, and conclusions
Benefit-Risk & Signal Assessment
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Perform active benefit-risk interpretation using cumulative safety information
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Review exposure estimates in the context of observed adverse events and emerging risks
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Interpret signal-detection outputs and assess potential safety signals
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Evaluate whether available evidence supports changes in the product safety profile
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Distinguish meaningful safety concerns from background variability or insufficient evidence
Safety Task Development
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Design realistic medical safety and drug-safety assignments
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Develop clear task instructions and expected deliverables
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Produce authoritative reference outputs for safety-analysis and aggregate-reporting workflows
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Define objective criteria for evaluating accuracy, completeness, and professional quality
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Create tasks that reflect how experienced safety professionals approach complex reporting work
Quality & Validation
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Review outputs for unsupported assertions, inconsistent data, and incomplete analysis
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Ensure findings remain traceable to the underlying evidence
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Evaluate whether conclusions are proportionate to the available safety data
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Maintain consistency across long-form safety documents and supporting datasets
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Apply professional medical-safety judgement throughout review and validation workflows
Ideal Profile
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5+ years of professional medical safety, drug safety, or related clinical safety experience, with 10–25 years preferred
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Demonstrated experience authoring aggregate safety reports across both pre-commercial and post-commercial settings
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Hands-on authorship experience with both DSURs and PBRERs
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Strong experience with cumulative safety data, exposure estimates, signal detection, and benefit-risk evaluation
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Comfortable performing complete fatal-case workups, including investigator-versus-sponsor causality assessment
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Experience reviewing adverse events, SAEs, patient narratives, discontinuations, and protocol deviations
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MD, PharmD, PhD, or equivalent advanced professional or academic qualification
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Strong scientific and medical judgement
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Excellent written communication and ability to produce complex, long-form safety documentation
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Based in the United States, Canada, or France
Engagement Details
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Part-time independent contractor engagement
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Fully remote
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Minimum availability of approximately 20–25 hours per week
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Availability of 30+ hours per week is preferred
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Flexible scheduling based on project requirements
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Compensation: $130–$180/hour
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Work may include clinical safety data generation, aggregate safety reporting, reference-output development, and evaluation design
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Projects may be extended, shortened, or concluded based on project needs and performance
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Work must be completed without using confidential or proprietary information belonging to any employer, sponsor, client, institution, or other third party
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H1-B and STEM OPT support is unavailable for this engagement
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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