Pharmacovigilance Expert - Remote Job at YO AI Labs, New York, NY

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  • YO AI Labs
  • New York, NY

Job Description

Job Description

Job Description

Job Title: Pharmacovigilance Expert

Job Type: Contractor
Location: Remote

Job Overview

We are seeking experienced Pharmacovigilance Experts to support an AI healthcare project by reviewing drug safety documentation, evaluating regulatory content, and improving AI-generated outputs. No AI experience is required—your pharmacovigilance expertise is what matters.

Key Responsibilities
  • Review and author DSURs, PSURs/PBRERs, and safety reports.
  • Evaluate safety signals and benefit-risk assessments.
  • Ensure compliance with ICH E2F, ICH E2C(R2), and GVP guidelines.
  • Analyze aggregate safety data and reconcile case information.
  • Review MedDRA coding, causality, seriousness, and expectedness.
  • Provide structured feedback to improve AI-generated content.
  • Maintain high standards of quality and regulatory compliance.
Required Skills
  • Pharmacovigilance
  • Drug Safety
  • DSUR/PSUR/PBRER Review
  • ICH E2F & ICH E2C(R2)
  • GVP Guidelines
  • Signal Management
  • Benefit-Risk Assessment
  • MedDRA Coding
  • Safety Data Analysis
  • Regulatory Documentation
  • Strong Written Communication
  • Attention to Detail
Preferred Qualifications
  • 5+ years of pharmacovigilance or drug safety experience.
  • Experience with DSURs, PSURs/PBRERs, and aggregate safety reports.
  • Strong knowledge of ICH E2F, ICH E2C(R2), and GVP.
  • Experience with signal management and safety data review.
  • Degree in Pharmacy, Medicine, Nursing, Life Sciences, or related field.
  • Experience in clinical safety, post-marketing surveillance, or CRO/pharmaceutical environments is a plus.

Job Tags

For contractors, Remote work

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