Pharmacovigilance - Remote

About the role

We are seeking an experienced Pharmacovigilance Expert to support AI-driven healthcare projects by reviewing and evaluating drug safety documentation. The role involves assessing safety reports, ensuring regulatory compliance, evaluating benefit-risk profiles, identifying data inconsistencies, and providing clear, evidence-based feedback to support AI model development.

Responsibilities

• Review and evaluate DSURs, PSURs/PBRERs, and regulatory safety documents.
• Assess signal management, benefit-risk analysis, and safety conclusions.
• Ensure compliance with ICH E2F, ICH E2C(R2), and GVP guidelines.
• Reconcile aggregate safety data and identify reporting discrepancies.
• Prepare structured, guideline-based safety assessments and written feedback.

Requirements

• 5+ years of Pharmacovigilance or Drug Safety experience.
• Experience authoring or reviewing DSURs and PSURs/PBRERs.
• Strong knowledge of ICH E2F, ICH E2C(R2), GVP, MedDRA, signal management, and benefit-risk assessment.
• Experience with regulatory documentation, aggregate safety data analysis, and causality assessment.
• Excellent analytical, attention to detail, and written communication skills.