2 дня назад
Pharmacovigilance Expert (AI)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Pharmacovigilance Expert (AI): Reviewing and evaluating drug safety documentation to support AI-driven healthcare projects with an accent on regulatory compliance and benefit-risk assessment. Focus on assessing signal management, reconciling aggregate safety data, and providing evidence-based feedback for AI model development.
Location: Remote
Company
provides specialized consulting services to support the development of AI-driven healthcare solutions.
What you will do
- Review and evaluate DSURs, PSURs/PBRERs, and other regulatory safety documents.
- Assess signal management, benefit-risk analysis, and safety conclusions.
- Ensure strict compliance with ICH E2F, ICH E2C(R2), and GVP guidelines.
- Reconcile aggregate safety data to identify and resolve reporting discrepancies.
- Prepare structured, guideline-based safety assessments and provide feedback to support AI model development.
Requirements
- 5+ years of professional experience in Pharmacovigilance or Drug Safety.
- Proven experience authoring or reviewing DSURs and PSURs/PBRERs.
- Strong knowledge of ICH E2F, ICH E2C(R2), GVP, and MedDRA.
- Expertise in signal management and benefit-risk assessment.
- Experience with regulatory documentation and causality assessment.
- Excellent analytical skills and high attention to detail in written communication.
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