Remote | Medical Safety & Drug Safety Expert — $130–$180/hour

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

• Generate and validate safety-focused clinical datasets
• Review adverse event and serious adverse event records for accuracy, consistency, and completeness
• Assess discontinuations, protocol deviations, and related safety information
• Determine whether safety conclusions are supported by the underlying patient and study data
• Identify missing, inconsistent, or clinically implausible information

Adverse Event & SAE Assessment

• Review adverse events and serious adverse events across clinical development programmes
• Assess seriousness, severity, expectedness, timing, and clinical context
• Evaluate causality assessments and supporting evidence
• Distinguish investigator causality from sponsor causality where relevant
• Identify cases requiring deeper review or additional clarification

Patient Narratives & Fatal-Case Review

• Develop and review detailed clinical safety narratives
• Assess chronology, medical history, concomitant treatment, exposure, and outcomes
• Ensure narratives accurately reflect the available safety data
• Perform comprehensive review of complex and fatal cases
• Identify unsupported conclusions, missing evidence, and inconsistencies in case interpretation

DSUR & PBRER Authoring

• Author complete Development Safety Update Reports (DSURs) and component sections
• Develop complete Periodic Benefit-Risk Evaluation Reports (PBRERs) and related content
• Integrate cumulative safety information across reporting periods
• Evaluate emerging safety findings against overall product exposure
• Maintain consistency across analyses, narratives, tables, and conclusions

Benefit-Risk & Signal Assessment

• Perform active benefit-risk interpretation using cumulative safety information
• Review exposure estimates in the context of observed adverse events and emerging risks
• Interpret signal-detection outputs and assess potential safety signals
• Evaluate whether available evidence supports changes in the product safety profile
• Distinguish meaningful safety concerns from background variability or insufficient evidence

Safety Task Development

• Design realistic medical safety and drug-safety assignments
• Develop clear task instructions and expected deliverables
• Produce authoritative reference outputs for safety-analysis and aggregate-reporting workflows
• Define objective criteria for evaluating accuracy, completeness, and professional quality
• Create tasks that reflect how experienced safety professionals approach complex reporting work

Quality & Validation

• Review outputs for unsupported assertions, inconsistent data, and incomplete analysis
• Ensure findings remain traceable to the underlying evidence
• Evaluate whether conclusions are proportionate to the available safety data
• Maintain consistency across long-form safety documents and supporting datasets
• Apply professional medical-safety judgement throughout review and validation workflows

Ideal Profile

• 5+ years of professional medical safety, drug safety, or related clinical safety experience, with 10–25 years preferred
• Demonstrated experience authoring aggregate safety reports across both pre-commercial and post-commercial settings
• Hands-on authorship experience with both DSURs and PBRERs
• Strong experience with cumulative safety data, exposure estimates, signal detection, and benefit-risk evaluation
• Comfortable performing complete fatal-case workups, including investigator-versus-sponsor causality assessment
• Experience reviewing adverse events, SAEs, patient narratives, discontinuations, and protocol deviations
• MD, PharmD, PhD, or equivalent advanced professional or academic qualification
• Strong scientific and medical judgement
• Excellent written communication and ability to produce complex, long-form safety documentation
• Based in the United States, Canada, or France

Engagement Details

• Part-time independent contractor engagement
• Fully remote
• Minimum availability of approximately 20–25 hours per week
• Availability of 30+ hours per week is preferred
• Flexible scheduling based on project requirements
• Compensation: $130–$180/hour
• Work may include clinical safety data generation, aggregate safety reporting, reference-output development, and evaluation design
• Projects may be extended, shortened, or concluded based on project needs and performance
• Work must be completed without using confidential or proprietary information belonging to any employer, sponsor, client, institution, or other third party
• 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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