Job Description
Pay rate: 54-64/hr
*depending on range
Medical Review Scientist (nurse)
• 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) (if applicable)
• Conduct reportability assessment for medical device associated events and /or product complaint associated events, and review 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 his/her supervisor
Inspection Readiness:
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
Knowledge and Skills:
• Knowledge of Case Management and medical review SOPs and regulatory requirements for pharmacovigilance
• Clinical knowledge of therapeutic area patient populations and drug class
• Proficiency in technical safety systems including Safety Database and medical coding
• Knowledge of safety data capture in Clinical Trials and Post Marketing setting
• Knowledge of clinical trials and drug development
• Knowledge of products and patient population (preferred)
Qualifications
• Clinical Nursing qualification and 3 years of related drug safety experience
• Medical Qualification (Nursing Degree); plus 5 years relevant work
Job Tags
Contract work,