Pharmacovigilance Expert - Remote

Job Title: Pharmacovigilance Expert

Job Type: Contractor

Location: Remote

Job Overview

We are seeking experienced Pharmacovigilance Experts to contribute their drug safety expertise to an innovative healthcare AI project. In this role, you will help improve next-generation AI systems by reviewing, evaluating, and refining pharmacovigilance documentation, safety reports, and regulatory content. No prior AI experience is required—your pharmacovigilance expertise, analytical skills, and commitment to data quality are what matter most.

Key Responsibilities

Author and review evaluation tasks based on DSURs, PSURs/PBRERs, safety data, and case-level records. Assess safety findings, signal evaluations, and benefit-risk conclusions for accuracy and regulatory alignment. Review reports for compliance with ICH E2F, ICH E2C(R2), and GVP guidelines. Analyze aggregate safety data and reconcile case counts, figures, and inconsistencies across data sources. Evaluate safety conclusions based on new data, events, and regulatory requirements. Provide structured written feedback and rationales to support AI-driven pharmacovigilance tools. Ensure accuracy, completeness, and quality of regulatory safety documentation.

Required Skills

Pharmacovigilance Drug Safety Report Authoring DSUR/PSUR/PBRER Review ICH E2F & ICH E2C(R2) Compliance GVP Guidelines Aggregate Safety Data Analysis Signal Management Benefit-Risk Assessment MedDRA Coding Seriousness & Causality Assessment Expectedness Determination Data Reconciliation Regulatory Documentation Structured Written Communication Attention to Detail

Preferred Qualifications

5+ years of pharmacovigilance or drug safety experience within a sponsor, CRO, or consulting environment. Proven experience authoring or reviewing DSURs and/or PSURs/PBRERs. Strong knowledge of ICH E2F, ICH E2C(R2), and GVP guidelines. Hands-on experience with signal management, benefit-risk assessment, MedDRA coding, and safety data analysis. Experience reconciling aggregate safety data with case-level information. Advanced degree in life sciences, pharmacy, nursing, medicine, or related fields (PharmD, MD, MSc, or equivalent). Experience in clinical development safety, post-marketing surveillance, QPPV/deputy QPPV roles, safety committees, or AI-assisted safety review tools is a plus.