Pharmacovigilance Expert (AI Healthcare)

Формат работы

remote (Global)

Тип работы

project

Грейд

senior

Английский

Вакансия из Hirify Global, списка международных tech-компаний
Для мэтча и отклика нужен Plus

Мэтч & Сопровод

Для мэтча с этой вакансией нужен Plus

Описание вакансии

Текст:

TL;DR

Pharmacovigilance Expert (AI Healthcare): Reviewing and evaluating drug safety documentation for AI-driven healthcare projects with an accent on regulatory compliance, aggregate safety data, and benefit-risk assessment. Focus on assessing DSURs and PSURs/PBRERs, evaluating signal management and safety conclusions, and identifying reporting discrepancies.

Location: Remote

Company

hirify.global delivers consulting support for AI-driven healthcare projects.

What you will do

Review and evaluate DSURs, PSURs/PBRERs, and other regulatory safety documents.
Assess signal management, benefit-risk profiles, and safety conclusions.
Check 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 evidence-based written feedback for AI model development.

Requirements

At least 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.

Culture & Benefits

Remote contract engagement.
Opportunity to support AI-driven healthcare projects through expert drug safety evaluation.

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