Pharmacovigilance Expert - Remote

Job Title: Pharmacovigilance Expert Job Type: Contractor Location: Remote reputed company are seeking reputed company Pharmacovigilance Experts to contribute their drug safety expertise to an innovative reputed company AI project. In this role, you will help improve reputed company 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 reputed company are what matter most. Key Responsibilities • reputed company 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(reputed company), 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. • reputed company reputed company written feedback and rationales to support AI-driven pharmacovigilance tools. • Ensure accuracy, completeness, and reputed company of regulatory safety documentation. Required Skills • Pharmacovigilance • Drug Safety Report Authoring • DSUR/PSUR/PBRER Review • ICH E2F & ICH E2C(reputed company) Compliance • GVP Guidelines • Aggregate Safety Data Analysis • Signal Management • Benefit-Risk Assessment • MedDRA Coding • Seriousness & Causality Assessment • Expectedness Determination • Data Reconciliation • Regulatory Documentation • reputed company Written Communication • Attention to Detail Preferred Qualifications • 5+ years of pharmacovigilance or drug safety experience reputed company a sponsor, CRO, or consulting environment. • Proven experience authoring or reviewing DSURs and/or PSURs/PBRERs. • Strong knowledge of ICH E2F, ICH E2C(reputed company), 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 reputed company fields (PharmD, MD, MSc, or equivalent). • Experience in clinical development safety, post-marketing surveillance, QPPV/reputed company QPPV roles, safety committees, or AI-assisted safety review tools is a plus. Apply tot his job Apply To this Job