Our Client, a Biopharmaceutical company, is looking for a Medical Safety Reviewer for their Thousand Oaks, CA/Remote location. Responsibilities: Execute the medical review of ICSRs (narratives, coding, expectedness, causality, and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports. Act as MSRT product lead as assigned. Execute ICSR case escalation as appropriate. Execute appropriate case follow-up per SOPs. Support medical coding conventions and systematic process improvements for ICSR medical review. Maintain list of expected terms in the auto label tool. Support Quality Assurance of ICSR medical review. Participate in Safety Assessment Team (SAT) meetings, if applicable. Conduct reportability assessments for medical device-associated events and product complaints, reviewing for potential product problems. Provide input on teams for interdepartmental and cross-functional initiatives, if applicable. Perform other duties related to the position as necessary, as defined in SOPs or as requested by supervisor. Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain inspection readiness. Serve as a point of contact for Health Authority Inspections and Internal Process Audits within the role's remit. Requirements: Knowledge of client Case Management and medical review SOPs and regulatory requirements for pharmacovigilance. Clinical knowledge of therapeutic area patient populations and drug classes. Proficiency in technical safety systems including Safety Database and medical coding. Knowledge of safety data capture in Clinical Trials and Post Marketing settings. Knowledge of clinical trials and drug development processes. Understanding of client products and patient populations (preferred). Clinical Nursing qualification and at least 3 years of related drug safety experience. Medical Qualification (Nursing Degree) plus 5 years of relevant work experience. Why Should You Apply? Health Benefits Referral Program Excellent growth and advancement opportunities As an equal opportunity employer, ICONMA provides an environment that supports and encourages all individuals regardless of race, color, religion, gender, sexual orientation, gender identity or expression, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by law. #J-18808-Ljbffr ICONMA
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