Sr. Pharmacovigilance Clinical Scientist

Job Description Our client, a world leader in biotechnology and gene therapy, is looking for an "Sr. Pharmacovigilance Clinical Scientist" based in South San Francisco, CA (Hybrid). Job Duration: Long Term Contract (Possibility Of Extension) Pay Rate : $65/hr on W2 Company Benefits: Medical Dental Vision Paid Sick leave 401K The Sr. PV Clinical Scientist supports US Patient Safety by providing expert clinical review, evaluation, and quality oversight of Individual Case Safety Reports (ICSRs) and adverse event (AE) information. This role ensures case processing, follow-up, labeling assessments, and Health Authority submissions comply with company SOPs, PV regulations, and applicable global requirements. The position works autonomously as a subject matter expert, supports vendor oversight, drives quality and process improvements, and may lead projects and train internal and external teams. Key Responsibilities Conductclinical review and quality assessment of AE/ICSR cases processedinternally or by vendors. Evaluatecase validity, seriousness, causality, labeling, and follow-uprequirements. Ensureaccurate and timely case processing in the global safety database. Monitorcase quality, error trends, vendor performance, and potential compliancerisks. SupportPV compliance with FDA, ICH, EMA, GVP, and applicable global regulations. Leadprocess improvements, SOP updates, training initiatives, and quality trendreporting. Supportvendor oversight, audits, inspections, reconciliations, and casetransmission verification. Overseefollow-up activities, correspondence, and data corrections. Supporttechnical and medical product complaint reporting and escalation. Collaboratewith cross-functional teams and serve as a subject matter expert forsafety-related activities. Preparepresentations, executive summaries, and scientific/medical documentation. Required Qualifications Healthcareprofessional degree such as RN/BSN/MSN, PharmD, RPh/BPharm, NP, MD ,or related qualification. 5-7+years of pharmacovigilance experience in a biopharmaceutical environment or equivalentclinical experience with strong knowledge of safety regulations. Strongexperience with ICSR case processing and clinical review . Knowledgeof FDA, ICH, EMA, GVP , and global pharmacovigilance regulations. Experiencewith medical/scientific writing, data entry, and project management. Stronganalytical, communication, organizational, and problem-solving skills. Abilityto work independently, manage complex issues, and collaborate effectivelywith internal teams and external vendors. #J-18808-Ljbffr Dawar Consulting, Inc.