Remote Position
Remote | Pharmacovigilance Expert — \$70–\$80/hour
🌍 Remote · United States
💼 Full-time
About the position 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 review complex drug-safety materials, assess aggregate and case-level information, evaluate signal and benefit-risk conclusions, and provide structured feedback grounded in current pharmacovigilance standards. No prior experience in AI is required.
Responsibilities
- Review DSURs, PSURs/PBRERs, and related safety documentation for accuracy, completeness, and regulatory relevance
- Assess interval and cumulative safety information and associated case-level data
- Apply ICH E2F, ICH E2C(R2), and relevant GVP requirements
- Review report structure, appendices, and data presentation
- Identify issues affecting the defensibility of safety conclusions
- Evaluate emerging and established safety signals and supporting evidence
- Assess benefit-risk conclusions across development-stage and post-marketing settings
- Apply MedDRA coding principles and review seriousness, causality, and expectedness determinations
- Reconcile aggregate conclusions with underlying case information
- Identify unsupported assumptions, classification issues, or changes affecting the overall safety profile
- Reconcile case counts, figures, and safety data across reports and source materials
- Identify discrepancies between aggregate and case-level information
- Review AI-generated pharmacovigilance content for technical and regulatory accuracy
- Provide clear written rationales explaining evaluation decisions and identified deficiencies
- Support consistent quality standards across pharmacovigilance evaluation tasks
Requirements
- 5+ years of pharmacovigilance or drug-safety experience
- Experience at a sponsor, CRO, or as an independent consultant
- Demonstrated experience authoring or reviewing DSURs and/or PSURs/PBRERs end to end
- Strong working knowledge of ICH E2F, ICH E2C(R2), and relevant GVP guidance
- Experience with signal management and benefit-risk assessment
- Hands-on MedDRA coding experience
- Strong knowledge of seriousness, causality, and expectedness assessment
- Demonstrated ability to reconcile aggregate and case-level safety data
- Strong regulatory-documentation, analytical, and written communication skills
- No prior AI-training or model-evaluation experience is required
Nice-to-haves
- Advanced degree in life sciences, pharmacy, nursing, medicine, or a related discipline is highly valuable
- Development-stage and post-marketing safety experience is advantageous
- QPPV, deputy QPPV, or safety-committee experience is beneficial
Benefits
- Independent contractor engagement
- Fully remote
- Compensation: \$70–\$80/hour
Apply To This Job