We are seeking experienced Pharmacovigilance Experts to contribute their drug safety expertise to an innovative healthcare AI project. 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 ResponsibilitiesAuthor 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 SkillsPharmacovigilanceDrug Safety Report AuthoringDSUR/PSUR/PBRER ReviewICH E2F & ICH E2C(R2) ComplianceGVP GuidelinesAggregate Safety Data AnalysisSignal ManagementBenefit-Risk AssessmentMedDRA CodingSeriousness & Causality AssessmentExpectedness DeterminationData ReconciliationRegulatory DocumentationStructured Written CommunicationAttention to DetailPreferred Qualifications5+ 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 rmacy, nursing, medicine, or related fields (PharmD, MD, MSc, or equivalent).Experience t-marketing surveillance, QPPV/deputy QPPV roles, safety committees, or AI-assisted safety review tools is a plus.
18 days ago