Pharmacovigilance Expert - Remote

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.