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

About the job 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 .