Job Title

Senior Pharmacovigilance Study Operations Lead We are currently looking for a fully remote Pharmacovigilance Operations Study Lead for a global pharmaceutical company on a 9 month contractual basis.Is this the role you are looking for If so read on for more details, and make sure to apply today.This is a fully remote role with a high chance of being extended.Key Responsibilities Case Management & Safety Data Oversight Lead the processing, review, and quality assurance of adverse event reports (ICSRs), ensuring compliance with global regulatory standards and internal protocols.Vendor and Compliance Management Oversee vendor performance in case processing, monitor KPIs, ensure quality control, and support compliance through training and regular audits.Process Optimization & Systems Support Improve pharmacovigilance workflows and systems by identifying process enhancements and contributing to SOP and policy development.Regulatory & Safety Reporting Prepare safety documentation for regulatory submissions, manage safety data accuracy, and respond to regulatory queries and audits.Cross-Functional Collaboration & Leadership Act as a liaison with clinical teams, mentor case management staff, support inspections, and lead operations in the managers absence.Candidate Requirements Education : Bachelors degree in a health-related or biological science field (required).Experience : Proven background in pharmacovigilance/drug safety, with strong understanding of global AE/ICSR regulatory requirements.Familiarity with safety databases, MedDRA coding, and medical terminology.Experience managing vendor relationships and supporting audits/inspections.Skills : Strong analytical, communication, and decision-making abilities.High attention to detail, organization, and time management.Proficient in Microsoft Office and safety database tools.Adaptable, collaborative, and capable of working in a dynamic environment.Willingness to work flexible hours as needed.