Washington, DC · Remote
$70 - $80/hr
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
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Washington, DC · Remote
$70 - $80/hr
Drug Safety Report Authoring * DSUR/PSUR/PBRER Review * ICH E2F & ICH E2C(R2) Compliance * GVP Guidelines * Aggregate Safety Data Analysis * Signal Management * Benefit-Risk Assessment * MedDRA ...
New
| Aspect | Psur Aggregate Report | Psur Data Analyst |
|---|---|---|
| Required Credentials | Typically no specific certifications, but familiarity with PSUR reporting standards | Often requires a degree in data analysis, healthcare, or related fields; certifications like CAP or PCAP are common |
| Work Environment | Regulatory or pharmaceutical settings, focusing on report compilation | Data analysis departments within pharma or healthcare companies, working with large datasets |
| Employer & Industry Usage | Used by regulatory agencies and pharmaceutical companies for safety reporting | Employed by pharma companies, CROs, or healthcare organizations for data interpretation |
The Psur Aggregate Report focuses on compiling and submitting safety data summaries for regulatory review, while the Psur Data Analyst interprets and analyzes the underlying data to support safety assessments. Both roles are integral to pharmacovigilance but differ in scope and responsibilities.
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$70 - $80/hr
Full-time
Posted 2 days ago
New
Job Type: Contractor
Location: Remote
We are seeking experienced Pharmacovigilance Experts to contribute their drug safety expertise to an innovative healthcare AI project. In this role, you will help improve next-generation AI systems by reviewing, evaluating, and refining pharmacovigilance documentation, safety reports, and regulatory content. No prior AI experience is required—your pharmacovigilance expertise, analytical skills, and commitment to data quality are what matter most.
Key ResponsibilitiesAuthor and review evaluation tasks based on DSURs, PSURs/PBRERs, safety data, and case-level records.
Assess safety findings, signal evaluations, and benefit-risk conclusions for accuracy and regulatory alignment.
Review reports for compliance with ICH E2F, ICH E2C(R2), and GVP guidelines.
Analyze aggregate safety data and reconcile case counts, figures, and inconsistencies across data sources.
Evaluate safety conclusions based on new data, events, and regulatory requirements.
Provide structured written feedback and rationales to support AI-driven pharmacovigilance tools.
Ensure accuracy, completeness, and quality of regulatory safety documentation.
Pharmacovigilance
Drug Safety Report Authoring
DSUR/PSUR/PBRER Review
ICH E2F & ICH E2C(R2) Compliance
GVP Guidelines
Aggregate Safety Data Analysis
Signal Management
Benefit-Risk Assessment
MedDRA Coding
Seriousness & Causality Assessment
Expectedness Determination
Data Reconciliation
Regulatory Documentation
Structured Written Communication
Attention to Detail
5+ years of pharmacovigilance or drug safety experience within a sponsor, CRO, or consulting environment.
Proven experience authoring or reviewing DSURs and/or PSURs/PBRERs.
Strong knowledge of ICH E2F, ICH E2C(R2), and GVP guidelines.
Hands-on experience with signal management, benefit-risk assessment, MedDRA coding, and safety data analysis.
Experience reconciling aggregate safety data with case-level information.
Advanced degree in life sciences, pharmacy, nursing, medicine, or related fields (PharmD, MD, MSc, or equivalent).
Experience in clinical development safety, post-marketing surveillance, QPPV/deputy QPPV roles, safety committees, or AI-assisted safety review tools is a plus.