Remote | Pharmacovigilance Expert — $70–$80/hour

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 author and review complex drug-safety evaluation tasks, assess aggregate and case-level safety information, evaluate signal and benefit-risk conclusions, and provide structured feedback grounded in current pharmacovigilance standards. The work requires strong regulatory judgement, data-reconciliation skills, and precise written communication. No prior experience in AI is required.

Key Responsibilities

Aggregate Safety Report Review

• Author and review evaluation tasks based on DSURs, PSURs/PBRERs, and related safety documentation
• Assess whether interval and cumulative safety information is accurately represented
• Evaluate report completeness, consistency, and regulatory relevance
• Review associated case-level records and supporting safety data
• Identify material issues affecting the defensibility of safety conclusions

ICH & GVP Compliance

• Assess conformity with ICH E2F requirements for Development Safety Update Reports
• Evaluate compliance with ICH E2C(R2) for PSURs/PBRERs
• Apply relevant GVP guidance to pharmacovigilance review tasks
• Review section structure, content, appendices, and data presentation
• Distinguish cumulative from interval safety information appropriately

Signal Management & Safety Evaluation

• Evaluate emerging and established safety signals
• Assess the adequacy of signal analyses and supporting evidence
• Review whether safety conclusions appropriately reflect new events or data
• Identify inconsistencies between reported findings and underlying case information
• Apply expert pharmacovigilance judgement to complex safety scenarios

Benefit-Risk Assessment

• Review benefit-risk conclusions across development-stage and post-marketing contexts
• Assess whether conclusions remain defensible as safety information evolves
• Identify unsupported assumptions or incomplete risk characterisation
• Evaluate whether new evidence changes the overall benefit-risk profile
• Provide structured rationales supporting safety determinations

MedDRA & Case-Level Assessment

• Apply MedDRA coding principles to safety data
• Evaluate seriousness and causality assessments
• Assess expectedness determinations
• Review case-level data for consistency with aggregate conclusions
• Identify clinically or regulatorily significant classification issues

Data Reconciliation & Quality Control

• Reconcile figures and case counts across report sections and source datasets
• Identify discrepancies between aggregate and case-level information
• Assess whether numerical inconsistencies are significant for regulatory review
• Document reconciliation findings clearly
• Support high standards of pharmacovigilance data quality

Regulatory Documentation & Written Rationale

• Review regulatory safety documentation for accuracy and completeness
• Provide clear, structured written explanations supporting evaluation decisions
• Identify omissions, ambiguities, or unsupported conclusions
• Translate complex pharmacovigilance reasoning into concise professional language
• Maintain strong documentation standards across project outputs

AI Safety Evaluation Support

• Review AI-generated pharmacovigilance content for technical and regulatory accuracy
• Identify incorrect safety interpretations or weak benefit-risk reasoning
• Provide detailed feedback to improve model performance
• Support development of AI-assisted pharmacovigilance documentation and analysis workflows
• Apply consistent domain standards across repeated evaluation tasks

Ideal Profile

• 5+ years of pharmacovigilance or drug-safety experience
• Experience working at a sponsor, CRO, or as an independent consultant
• Demonstrated proficiency authoring or reviewing DSURs and/or PSURs/PBRERs from start to finish
• Strong working knowledge of ICH E2F and ICH E2C(R2)
• Familiarity with relevant GVP guidelines
• Experience with signal management and benefit-risk assessment methodology
• Hands-on experience with MedDRA coding
• Strong knowledge of seriousness and causality assessment
• Experience with expectedness determination
• Strong aggregate safety-data analysis skills
• Demonstrated ability to reconcile aggregate and case-level safety information
• Strong regulatory-documentation skills
• Excellent attention to detail
• Strong written communication and analytical judgement
• Advanced degree in life sciences, pharmacy, nursing, medicine, or a related discipline is highly valuable
• Experience across both development-stage and post-marketing safety reporting is advantageous
• QPPV or deputy QPPV experience is beneficial
• Safety-committee participation is advantageous
• Exposure to AI-assisted safety-review tools is a plus but not required
• 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
• Strong pharmacovigilance and drug-safety judgement are central to this engagement
• 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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