[Hiring] Medical Safety & Drug Safety Expert @24-MAG

Role Description

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

Qualifications

• 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