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.

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